Reflections on my tour of the Soteria Project at St Hedwig Hospital, Berlin

A fabulous, enlightened experiment in Berlin with humane treatment of patients suffering severe mental disorder that we cannot reproduce in the United States.

 

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A fabulous, enlightened experiment in Berlin with humane treatment of patients suffering severe mental disorder that we cannot reproduce in the United States.

soteria doorI visited the Soteria project at St Hedwig Hospital, Berlin at the invitation of Professor Andreas Heinz, Director and Chair of the Department of Psychiatry and Psychotherapy at the Charité— Universitätsmedizin Berlin.

I was actually coming to St Hedwig Hospital, Berlin to give a talk on scientific writing, and was surprised by an offer of a tour of their Soteria Project.

I came away with great respect for a wonderful experiment in the treatment of psychosis that must be protected.

outside SoteriaI was also saddened to realize that such treatment could not conceivably be offered in the United States, even for patients with families who could pay large expenses out of pocket.

In Germany, financial arrangements allow months for the stabilization of acutely psychotic patients. The question is how best to use these resources.

 

In contrast, newly admitted patients in the United States generally are allowed only stays of 48 to 72 hours at the most to stabilize. Inpatient psychiatric beds are in short supply, and often unavailable to those who can afford to pay out of pocket.

The largest inpatient psychiatric facility in the United States is the Los Angeles County jail, where patients are thrown in with criminal populations or forced into anti-suicide smocks and isolated. Access to mental care in the jail is highly restricted.

In United States, the challenge is to get minimal resources to vulnerable severely disturbed population. Efforts to do so must compete with diversion of mental health funds to populations much less in need but amenable to outpatient psychotherapy.

It takes a mass killing to activate calls for better psychiatric care for the severely disturbed, on the false promise that better and more accessible care will measurably reduce mass killings. Of course, this is all a distraction from the need to restrict the firearms used in mass killings.

Professor Heinz and I became friends when I critiqued his study of open versus locked inpatient psychiatric wards, Why Lancet Psychiatry study didn’t show locked inpatient wards ineffective in reducing suicide   . We can still agree to disagree about the interpretation of complex observational/administrative data, but we came to appreciate differences in our sociocultural perspectives.

In my blog I was actually taking aim at Mental Elf’s pandering to the anti-psychiatry crowd with the goofy claim of the lack of “any compelling evidence that locking people up actually increases safety.” Sometimes vulnerable psychotic and suicidal persons need to be protected from themselves.

Furthermore, experimentation with unlocked wards frquently   come to an end with the suicide of a single absconding patient.

In Germany, better staffing and time to develop better relationships with patients allow much more respect for patient autonomy and self-responsibility. But open wards are always vulnerable to these adverse events.

The original Soteria, Palo Alto Project

I came to St Hedwigs with negative feelings about the  original Soteria Project. I was Director of Research at MRI Palo Alto in 1980s when it was housed there. I came away thinking its strong anti-psychiatry attitude was disastrous and led to much harm when it got disseminated.

Loren Mosher and Alma Menn were determined to demonstrate that antipsychotic medication was unnecessary in treatong psychotic patients.

Frankly, Moher and Menn were so committed to their ideological position, they distorted presentation of  their data. They misprepresented comparisons between disparate community mental health and Soteria samples as randomized trials. They relied on a huge selection bias and unreliable diagnoses that lumped acutely maniac patients and personality disorders with patients with schizophrenia. They tortured their data with a variety of p- hacking techniques and still didn’t come up with much.

After Soteria Palo Alto closed, an effort to get an NIMH grant for follow-up failed because the initial presentations of patients was so badly recorded that no retrospective diagnosis was possible.

Subsequent Soteria projects around the world have had a full range of attitudes towards the role of medication in the treatment of vulnerable and highly disorganized patients.

St Hedwig has an  enlightened, evidence informed approach that of course includes judicious use of antipsychotics. Antipsychotic medication is provided with acutely psychotic patients, but at an appropriate dosage. Patient response is closely monitored and tapering is attempted when there is improvement. Importantly, decisions about medication prioritize patient well-being, not staff convenience..

The best evidence is that patients who experiencing  episodes of unmedicated psychosis are increasingly doomed to poor recovery of social and personal functioning. On the other hand, particularly with treatment of ambiguous acute first episodes, has to be a lot of monitoring and reconsideration of medication. In understaffed and underresourced American psychiatric settings, there is little monitoring antipsychotic medications and little efforts at tapering. Furthermore, dosages often excessively high because that makes patients more manageable for overwhelmed staff. Overmedicated patients are easier to handle

Unfortunately, the quality of care offered in Berlin is unimaginable in the US even for those who can afford to pay out of pocket.

group meetingWith Professor Heinz’s permission, here is a refined Google translation of the Project website.

See also  an excellent discussion of the thinking that went into the architecture of Soteria, aimed at maximizing its potential as a therapeutic environment.

around the hearth

Special thanks also to Psychiatrists Dr med Felix Bermpohl and Dr med Martin Voss Oberarzt.

SOTERIA

Soteria’s program at the Charité’s Psychiatric University Clinic in the St. Hedwig Hospital is aimed at young people who are in an acute psychotic crisis, who are afraid of the onset of a psychosis, or who still need a professional stationary environment after a psychotic crisis.

There are 12 treatment rooms in the Soteria. Since the Soteria works within the scope of the compulsory supply, these places are intended exclusively for people from the districts of Wedding, Mitte, Tiergarten and Moabit.

[note from Prof Heinz: The difficult to translate passage refers to our hospital having a catchment area, from which we have to take every patient who wishes to be admitted and particularly every compulsory admission. We serve one of the poorest areas in Berlin, so we do not do “raisin picking” of easy to treat patients.]

“Soteria” (ancient Greek: healing, well-being, preservation, salvation) denotes a special treatment approach for people in psychotic crises with the so-called “milieutherapy”.

The residential environment, the co-patients, the attitude of the therapists as well as the orientation towards normality and “real life” outside the clinic represent the therapeutic milieu. Patients and employees meet in therapeutic communities on the same level and shape together – with the involvement of the social Environment – the day.

The psychosis treatment takes place in the form of active “being-yourself”, if necessary also in continuous 1: 1 care in the so-called “soft room”. The healing therapeutic milieu provides protection, calming and relief of tension, so that psychopharmaceuticals can be used very cautiously. This medication-saving effect of the soteria treatment is scientifically well documented, among other positive effects. (1)

1) Calton, T. et al. (2008): A Systematic Review of the Soteria Paradigm for the Treatment of People Diagnosed With Schizophrenia. Schizophrenia Bulletin 34,1:181-192;

2) L. Ciompi, H. Hoffmann, M. Broccard (Hrsg.), Wie wirkt Soteria? Online Ausgabe (2011), Heidelberg: Carl-Auer-System-Verlag.

3) Hl. Thérèse von Lisieux: Nonne, Mystikerin, KirchenlehrerinGeboren: 2. Januar 1873 in Alencon in der Normandie in Frankreich Verstorben: 30. September 1897 in Lisieux in Frankreich

The reports on the original Soteria, Palo Alto project

Mosher LR, Menn AZ, Matthew SM. Soteria: evaluation of a home-based treatment for schizophrenia. Am J Orthopsychiatry. 1975;45:455–467. [PubMed]

Mosher LR. Implications of family studies for the treatment of schizophrenia. Ir Med J. 1976;69:456–463. [PubMed]

Mosher LR, Menn AZ. Soteria: an alternative to hospitalisation for schizophrenia. Curr Psychiatr Ther. 1975;15:287–296. [PubMed]

Mosher LR, Menn AZ. Soteria House: one year outcome data. Psychopharmacol Bull. 1977;13:46–48.[PubMed]

Mosher LR, Menn AZ. Community residential treatment for schizophrenia: two-year follow-up. Hosp Community Psychiatry. 1978;29:715–723. [PubMed]

Mosher LR, Menn AZ. Soteria: an alternative to hospitalisation for schizophrenics. Curr Psychiatr Ther. 1982;21:189–203. [PubMed]

Matthews SM, Roper MT, Mosher LR, Menn AZ. A non-neuroleptic treatment for schizophrenia: analysis of the two-year post-discharge risk of relapse. Schizophr Bull. 1979;5:322–333. [PubMed]

Mosher LR, Vallone R, Menn AZ. The treatment of acute psychosis without neuroleptics: six-week psychopathology outcome data from the Soteria project. Int J Soc Psychiatry. 1995;41:157–173. [PubMed]

Mosher LR. Soteria and other alternatives to acute psychiatric hospitalisation. J Nerv Ment Dis. 1999;187:142–149. [PubMed]

About Professor Heinz

Andreas Heinz is Director and Chair of the Department of Psychiatry and Psychotherapy at the Charité— Universitätsmedizin Berlin.

He is the author of the just released A New Understanding of Mental Disorders: Computational Models for Dimensional Psychiatry, MIT Press, 2017.

 

 

Results of largest trial of suicide intervention in emergency departments ever conducted in US

The NIMH issued a press release about the publication in JAMA Psychiatry of results of the ED-SAFE Study, the largest suicide intervention trial ever conducted in emergency departments (ED) in US.

NIMH

“We expect that EDs are capable of helping individuals at risk for suicide attempts. Earlier ED-SAFE study findings showed that brief universal screening could improve detection of more individuals at risk,”, said Jane Pearson, Ph.D., chair of the Suicide Research Consortium at the NIMH. “These recent findings show that if ED care also includes further assessment, safety planning, and telephone-based support after discharge, there is a significant reduction in later suicide attempts among adults.”

“We were happy that we were able to find these results,” said lead author Ivan Miller, Ph.D., Professor of Psychiatry and Human Behavior at Brown University, Providence, Rhode Island. “We would like to have had an even stronger effect, but the fact that we were able to impact attempts with this population and with a relatively limited intervention is encouraging.”

The report of the study in JAMA Psychiatry

Miller IW, Camargo CA, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Jones R, Hasegawa K, Boudreaux ED. Suicide prevention in an emergency department population: the ED-SAFE Study. JAMA Psychiatry. 2017 Apr 29.

The recently revamped website for the JAMA network of journals provided updated reports of the heavy traffic being drawn in by the article.

The new Key Points feature for important articles gave succinct, more quickly digestible summary of the study than the similarly spun abstract.

Key Points

Question  Do emergency department (ED)–initiated interventions reduce subsequent suicidal behavior among a sample of high-risk ED patients?

Findings  In this multicenter study of 1376 ED patients with recent suicide attempts or ideation, compared with treatment as usual, an intervention consisting of secondary suicide risk screening by the ED physician, discharge resources, and post-ED telephone calls focused on reducing suicide risk resulted in a 5% absolute decrease in the proportion of patients subsequently attempting suicide and a 30% decrease in the total number of suicide attempts over a 52-week follow-up period.

Meaning  For ED patients at risk for suicide, a multifaceted intervention can reduce future suicidal behavior.

The abstract elaborates:

Results  A total of 1376 participants were recruited, including 769 females (55.9%) with a median (interquartile range) age of 37 (26-47) years. A total of 288 participants (20.9%) made at least 1 suicide attempt, and there were 548 total suicide attempts among participants. There were no significant differences in risk reduction between the TAU and screening phases (23% vs 22%, respectively). However, compared with the TAU phase, patients in the intervention phase showed a 5% absolute reduction in suicide attempt risk (23% vs 18%), with a relative risk reduction of 20%. Participants in the intervention phase had 30% fewer total suicide attempts than participants in the TAU phase. Negative binomial regression analysis indicated that the participants in the intervention phase had significantly fewer total suicide attempts than participants in the TAU phase (incidence rate ratio, 0.72; 95% CI, 0.52-1.00; P = .05) but no differences between the TAU and screening phases (incidence rate ratio, 1.00; 95% CI, 0.71-1.41; P = .99).

I have the benefit of having read the entire article a number of times, but there are some notable statistics being reported in the abstract and some crucial things being left out.

The phase of the study that involved only introducing screening into treatment as usual (TAU) had no effect on suicide attempts (p= .99). The claim of an effect of the more extensive intervention on suicide attempts depends on multivariate analyses that include a confidence interval that includes 1.0. (incidence rate ratio, 0.72; 95% CI, 0.52-1.00; P = .05).

From JAMA Psychiatry

Results are quite weak, at best. Pairwise comparisons are being reporting, first the screening versus TAU, then the more extensive intervention versus TAU. Missing is any reporting of the overall ANOVA testing whether there is at least one significant pairwise difference between groups. Obtaining such a significant difference would justify a post hoc look at the specific pairs. Given what we have already been told in the abstract, it is safe to assume no overall effect. This is a null trial. If we stuck to a priori statistical plans, we would have to say that a phased-in, comprehensive intervention with suicidal patients presenting in an emergency room failed to impact subsequent suicide attempts.

These findings contradict the statement of the NIMH Chair of the Suicide Research Consortium.

I know, it is arbitrary to make go/no go decisions based on an arbitrary level of significance, p< .05 or whatever. Yet, the implement/don’t implement and evidence-supported/not evidence-supported distinctions are binary. The best we can do is to set criteria based on a power analysis and avoid switching criteria when we don’t obtain the results that we would have liked.

We can stop here in our critique with the usual messages to avoid spinning of results in order to obtain politically expedient and socially satisfying, even if inaccurate conclusions.  Once again, results of a trial are being exaggerated to justify a conclusion to which the researchers and policy makers are already committed.

But there is a lot more to be learned from this report of a large and historically significant trial.

Who was enrolled and what treatments were offered?

1376 adult participants were selected from persons presenting to 8 emergency departments across 7 states with participants with a suicide attempt or ideation within the week prior to the ED visit. Patients under 18 were excluded.

In the TAU phase, participants were treated according to the usual and customary care at each site, serving as the control for the subsequent study phases.

In the screening phase, sites implemented clinical protocols with universal suicide risk screening (the Patient Safety Screener) for all ED patients.

In the intervention phase, in addition to universal screening, all sites implemented a 3-component intervention: (1) a secondary suicide risk screening designed for ED physicians to evaluate suicide risk following an initial positive screen, (2) the provision of a self-administered safety plan and information to patients by nursing staff, and (3) a series of telephone calls to the participant, with the optional involvement of their significant other (SO), for 52 weeks following the index ED visit.

The outcome

The outcome was the proportion of patients who made a suicide attempt and the total number of suicide attempts occurring during the 52-week follow-up period.

Overall, of 1376 participants, 288 (20.9%) made at least 1 suicide attempt during the 12-month period. In the TAU phase, 114 of 497 participants (22.9%) made a suicide attempt, compared with 81 of 377 participants (21.5%) in the screening phase and 92 of 502 participants (18.3%) in the intervention phase. Five attempts were fatal, with fatalities observed in the TAU phase (n = 2) and intervention phase (n = 3).

Suicide attempts can be interpreted as an outcome in itself or as a surrogate outcome for deaths by suicide. Despite the substantial sample size, there is no way that this study could have demonstrated a significant reduction in deaths by suicide. That reflects the infrequency of death by suicide, even in such a high risk population. The ratio of 57.6 suicide attempts per one death by suicide is much higher than what is typically observed (usually in the range of 100 or so per suicide. This probably reflects the high risk nature of this population, as well as the methodology for determining the serious of suicide attempts.

More evidence that screening for suicide doesn’t improve outcomes

This study adds to an accumulation of a lack of evidence that routine screening for suicide is either efficient or leads to less suicides.

Previously, I blogged about the SEYLE trial of a school-based intervention to prevent teen suicide. It was a large RCT, but failed to demonstrate that screening affected the likelihood of a suicide attempt.  The null findings for the Screening by Professionals programme (ProfScreen) of SEYLE are generally downplayed.

Another blog post Use of scales to assess risk for a suicide attempt wastes valuable clinical resources discussed a large UK study that found none of the commonly used screening scales were clinically useful in predicting subsequent suicide.

That study concluded

Risk scales following self-harm have limited clinical utility and may waste valuable resources. Most scales performed no better than clinician or patient ratings of risk. Some performed considerably worse. Positive predictive values were modest. In line with national guidelines, risk scales should not be used to determine patient management or predict self-harm.

Nonetheless there is:

The Joint Commission.  Detecting and treating suicide ideation in all settings.  Sentinel Event Alert. 2016;(56):1-7.

The Joint Commission is a United States-based nonprofit tax-exempt 501(c) organization[1] that accredits more than 21,000 health care organizations and programs in the United States. The Joint Commission recommends that hospitals routinely screen patients for risk of suicide.

An editorial accompanying the JAMA Psychiatry report cited this recommendation as part of the rationale of the ED-SAFE  study and warned of implementing screening without resources:

Since the alert, many hospitals have implemented suicide risk screening without the benefit of evidence-based tools and clinical pathways, potentially increasing the risk of underdetection (ie, false-negatives) or overburdening limited mental health resources with false-positives.

Most patients in the ED-SAFE study were not recorded as receiving the intervention as intended.

Medical record review indicated that 449 of 502 participants (89.4%) had received a suicide risk assessment from their physician, but only 17 (3.9%) had documentation of the ED-SAFE standardized secondary screening was used.

And

Among those participants who completed the initial CLASP call, 114 (37.4%) reported having received a written safety plan in the ED.

You cannot fault these researchers for having failed to make a concerted effort to train personnel in the participating sites or to systematically implement the study protocol. See

Boudreaux ED, Camargo CA, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Miller IW. Improving suicide risk screening and detection in the emergency department. American Journal of Preventive Medicine. 2016 Apr 30;50(4):445-53.

A wealth of evidence suggests that is it is difficult to implement formal screening with self-report and interviewer-completed checklists in medical settings. Most medical personnel find such instruments intrusive and they are not efficient, anyway. Alex Mitchell and I documented this in our book, Screening for Depression in Clinical Practice: An Evidence-Based Guide

.In both the screening and intervention phase, it was difficult to get adherence to the protocol, in part  because patients entering EDs are not necessarily cooperative. But more importantly, EDs in this study were not well-connected to the specialty mental health services needed for timely follow up. The accompanying editorial notes:

Although EDs have been conceptualized as key sites to identify and treat individuals at high risk for suicide,8 the troubling reality is that mental health resources are not available in most American EDs, and few universally screen for suicide risk.9,10 Notably, participating ED-SAFE study sites did not have psychiatric services within or adjacent to the ED in order to increase generalizability. Although time constraints, inadequate training, and lack of proper screening instruments have been cited as reasons clinicians do not routinely screen for suicide risk,8,10,11 the absence of psychiatric services in most EDs reflects disproportionately low cultural expectations of the ED in addressing potentially life-threatening mental health crises.

The realignment and reallocation of resources needed to address this practical and structural problem are not easily obtained. Clinical instances in which quick referral and follow up of a seriously suicidal patient are relatively infrequent. It is difficult to maintain the personnel and resources unencumbered until they are needed, especially in the face of  other, pressing competing demands.

How will ED-SAFE be cited and entered into the accumulating literature concerning the difficulty getting reductions in lives lost to suicide?

The article reports the Number Needed to Treat (NNT) for patients receiving the comprehensive ED-SAFE intervention:

The NNT to prevent future suicidal behavior ranged between 13 and 22. This level of risk reduction compares favorably with other interventions to prevent major health issues, including statins to prevent heart attack (NNT = 104),23 antiplatelet therapy for acute ischemic stroke (NNT = 143),24 and vaccines to prevent influenza in elderly individuals (NNT = 20).25

But if the intervention is not effective, NNTs are misleading.

If the NIMH press release is taken as a sign, the ED-SAFE intervention will be interpreted as impressively effective. However, despite some spinning, the ED-SAFE researchers present the problems they encountered and the results they obtained in a way that the formidable obstacles to such a well-conceived effort succeeding are apparent. It would be unfortunate if the lessons to be learned are missed.

 

 

 

 

Were any interventions to prevent teen suicide effective in the SEYLE trial?

Disclaimer: I’ve worked closely with some of the SEYLE investigators on other projects. I have great respect for their work. Saving and Empowering Young Lives in Europe was a complex, multisite suicide prevention project of historical size and scale that was exceptionally well implemented.

However, I don’t believe that The Lancet article reported primary outcomes in a way that their clinical and public health significance can be fully and accurately appreciated. Some seemingly positive results were reported with a confirmation bias. Important negative findings were reported in ways that they are likely to be ignored, losing important lessons for the future.

I don’t think we benefit from minmizing the great difficulty in showing that any interventions work to prevent death by suicide, particularly in a relatively low risk group like teens. We don’t benefit from exaggerating the strength of evidence for particular approaches.

The issue of strength of evidence is compounded by Danuta Wasserman, the first author also being among the authors of a systematic review.

Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Höschl C, Barzilay R, Balazs J, Purebl G. Suicide prevention strategies revisited: 10-year systematic review. The Lancet Psychiatry. 2016 Jul 31;3(7):646-59.

In a post at Mental Elf, psychiatrist and expert on suicidology  Stanley Kutcher pointed to a passage in the abstract of the systematic review:

The review’s abstract notes that YAM (one of the study arms) “was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0.45, 95% CI 0.24 to 0.85; p=0.014) and severe suicidal ideation (0.50, 0.27 to 0.92; p=0.025)”. If this analysis seems familiar to the reader that is because this is the information also provided in the Zalsman abstract! This analysis refers to the SELYE study ONLY! However, the way in which the Zalsman abstract is written suggests this analysis refers to all school based suicide awareness programs the reviewers evaluated. Misleading at best. Conclusion supporting, not at all.

[Another reminder that authors of major studies should not also be authors on systematic reviews and meta analyses that review their work. But tell that to Cochrane Collaboration, which now has a policy of inviting authors of studies from which individual data are needed. But that is for another blog post.]

The article reporting the trial is currently available open access here.

Wasserman D, Hoven CW, Wasserman C, Wall M, Eisenberg R, Hadlaczky G, Kelleher I, Sarchiapone M, Apter A, Balazs J, Bobes J. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial. The Lancet. 2015 Apr 24;385(9977):1536-44.

The trial protocol is available here.

Wasserman D, Carli V, Wasserman C, et al. Saving and empowering young lives in Europe (SEYLE): a randomized controlled trial. BMC Public Health 2010; 10: 192.

seyle protocol

 

 

From the abstract of the Lancet paper:

Methods. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11 110 adolescent pupils, median age 15 years (IQR 14–15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up…

No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24–0·85; p=0·014) and severe suicidal ideation (0·50, 0·27–0·92; p=0·025), compared with the control group. 14 pupils (0·70%) reported incident suicide attempts at the 12 month follow-up in the YAM versus 34 (1·51%) in the control group, and 15 pupils (0·75%) reported incident severe suicidal ideation in the YAM group versus 31 (1·37%) in the control group. No participants completed suicide during the study period.

What can be noticed right away: (1) this is a four-armed study in which three interventions are compared to the control group; (2) apparently there were no effects observed at three months; (3) results are not reported for three of the four interventions at 12 months, only differences for one of the intervention group versus the control group; (4) the differences between the intervention group and the control group were numerically small; (5) despite enrolling over 11,000 students, no suicides were observed in any of the groups.

[A curious thing about the abstract to be discussed later in the post. What is identified as the statistical effect of YAM on self-reported suicide attempts is expressed in an odds ratio and statistical significance. No actual number are given. Yet, e

Effects on suicidal ideation are expressed in absolute numbers, with a small number of students identified as having severe ideation and a small absolute difference between YAM and the control group. Presumably, there were fewer suicide attempts than students with severe ideation. Like me, are you wondering how may self-reported attempts we are talking about?]

This study did not target actual suicides. That decision is appropriate, because even with 11,000 students there were no suicides. The significance of the lack of suicides is even with this many students followed for a year, one might not even have a single suicide, and so one cannot expect to observe an actual decrease in suicides, and certainly not a statistically significant decrease.

We should keep this in mind the next time we encounter claims about teen suicides being an epidemic or expectation that an intervention a particular community will lead to an observable reduction in teen suicides.

We should also keep this in mind when we see in the future that a community implemented suicide prevention programs after some spike in suicides. It’s very likely that a reduction in suicides will be observed, but that’s simply regression to the mean, the community returned to more typical rates of suicide.

hilda surrogate outcomesRather than actual suicides, the study specified suicidal ideation and self-reported suicidal acts. We have to be cautious about inferring changes in suicide from changes in these surrogate outcomes. Changes in surrogate outcomes don’t necessarily translate into changes in the outcomes that we are most interested in, but for whatever reason are not measuring. In this study, investigators were convinced with even such a large sample, a reduction in suicides would not be observed. Hardly a reason to argue that  whatever reduction in surrogate outcomes is observed would translate into a reduction in deaths.

Let’s temporarily put aside the issue of suicidal acts being self-reported and subject to both on unreliability and a likely overestimate of life-threatening acts. I would estimate from other studies that one would have to prevent hundred documented attempts at suicide in order to prevent one actual suicide.

But these are self-report measures.

Pupils  were identified as having severe suicidal ideation, if they answered: “sometimes, often, very often or always”  to the question: “during the past 2 weeks, have you  reached the point where you seriously considered  taking your life, or perhaps made plans how you would go about doing it?”

So any endorsement  of any of these categories were lumped together as “severe ideation.” We might not agree with that designation, but without this lumping, a sample of 11,000 students does not yield differences in occurrences of “severe suicidal ideation.”

Readers are not given a breakdown of the endorsements of suicidality across categories, but I think we can reasonably make some extrapolations about the skewness of the distribution from a study that I blogged about of the screening of 10,000 postpartum women  with a single item question:

In the sample of 10 000 women who underwent screening, 319 (3.2%) had thoughts of self-harm, including 8 who endorsed “yes, quite often”; 65, “sometimes”; and 246, “hardly ever.”

We can be confident that most instances of “severe suicidal ideation” in the SEYLE study did not indicate a strong likelihood of a teen making a suicide attempt. Such self-report measures are more related to other depressive symptoms than to attempted suicide.

This is all yet a reminder of the difficulty targeting suicide as a public health outcome. It’s very difficult to show an effect.

The abstract of the article prominently features a claim that one of three interventions was different than the control group in severe suicidal ideation and suicide attempts at 12 months, but not at three months.

We should be left pondering what happened at 12 months with respect to two of the three interventions. The interventions were carefully selected and we have the opportunity to examine what effect they had. After all, we may not get another opportunity to evaluate such interventions in such a large sample in the near future. We might simply assume these interventions had no effect at 12 months, but the abstract is written to distract from that potentially important finding that has significance for future trials.

But there is another problem in the reporting of outcomes. The results section states:

Analyses of the interaction between intervention groups and time (3 months and 12 months) showed no significant effect on incident suicide attempts in the three intervention groups, compared with the control group at the 3 month follow-up.

And

After analyses of the interaction between intervention groups and time (3 months and 12 months), we noted the following results for severe suicidal ideation: at the 3 month follow-up, there were no signifi cant effects of QPR, YAM, or ProfScreen compared with the control group.

It’s not appropriate to focus on the difference between one of the interventions and the control group without taken into account the context of it being a four-armed trial, a a 4 (conditions)  x  2 (3 or 12 follow up) design.

In the absence of a clearly specified a priori hypothesis, we should first look to the condition x time interaction effect. If we can reject the null hypothesis of no interaction effect having occurred, we should then examine where the effect occurred, more confident that there is something to be explained. However, if we do what was done in the abstract, we need to appreciate the high likelihood of spurious effects when we single out one difference between one of the intervention groups and the control group at one of the two times.

Let’s delve into a table of results for suicide attempts:

self-report attempts

These results demonstrate  we should not make too much of YAM being statistically significant, compared to compared to the two other active intervention groups.

We’re talking about a difference of only a few numbers in suicide attempts of students assigned to YAM versus the other two active intervention groups.

On this basis of theses differences, are we willing to say that YAM represents best practices, an empirically based approach to preventing suicides in schools, whereas the other two interventions are ineffective?

Note that even the difference between YAM in the control group has a broad confidence interval around a different significant at the level of p<.014.

It gets worse. Note that these are not differences in actual attempts but results obtained with an imputation:

A multiple imputation procedure  35(50 imputations with full conditional specification for dichotomous variables)36was used to manage missing values of individual characteristics  (<1% missing for each individual characteristic), so that all pupils with an outcome at 3 months or 12 months  were included in the GLMMs. Additional models,  including sex-by-intervention group interactions, and age-by-intervention group interactions were tested for differential intervention effects by sex and age. To assess the robustness of the findings, tests for intervention group differences were redone including only the subset of pupils with complete outcome data at both 3 months and 12 months.

Overall, we are dealing with small numbers of events that likely assessed with considerable error of measurement occurring with multiple imputation procedures, with the possibility of specification error based on false assumptions that cannot be tested with such a small number of events. Then, we have the broad overlapping confidence intervals for the three interventions. Finally, there is the problem of not taking into account the multiple pairwise comparisons that were possible in this 3x (2) design in which the critical overall treatment x time interaction was not significant.

Misclassification of just a couple of events or  a recovery of data that were thought to be lost and therefore had to be estimated with imputation could alter significance levels – as if they really matter in such a large trial, anyway.

Let’s return to the issue of the systematic review in which the senior author of the SEYLE trial participated. The text in the abstract borrowed without attribution from the abstract of this SEYLE study reflects a bit of overenthusiasm or at least premature enthusiasm for the senior author’s own results.

Let’s look at the interventions that were actually evaluated. The three active interventions:

The Screening by Professionals programme (ProfScreen)…is a selective or indicated intervention based on responses to the SEYLE baseline questionnaire. When pupils had completed the baseline assessment, health professionals reviewed their answers and pupils who screened at or above pre-established cutoff points were invited to participate in a professional mental health clinical assessment and subsequently referred to clinical services, if needed.3

Question, Persuade, and Refer (QPR) is a manualized gatekeeper programme, developed in the USA.28 In SEYLE, QPR was used to train teachers and other school personnel to recognise the risk of suicidal behaviour in pupils and to enhance their communication skills to motivate and help pupils at risk of suicide to seek professional care. QPR training materials included standard power point presentations and a 34-page booklet distributed to all trainees.

Teachers were also given cards with local health-care contact information for distribution to pupils identified by them as being at risk. Although QPR targeted all school staff, it was, in effect, a selective approach, because only pupils recognised as being at suicidal risk were approached by the gatekeepers (trained school personnel).

YAM

The Youth Aware of Mental Health Programme (YAM) was developed for the SEYLE study29 and is a manualised, universal intervention targeting all pupils, which includes 3 h of role-play sessions with interactive workshops combined with a 32-page booklet that pupils could take home, six educational posters displayed in each participating classroom and two 1 h interactive lectures about mental health at the beginning and end of the intervention. YAM aimed to raise mental health awareness about risk and protective factors associated with suicide, including knowledge about depression and anxiety, and to enhance the skills needed to deal with adverse life events, stress, and suicidal behaviours.

This programme was implemented at each site by instructors trained in the methodology through a detailed 31 page instruction manual.

I of course could be criticized as offering my predictions about effects of these interventions after results are known. Nonetheless, I think my skepticism is well known and the criticisms I have of these interventions might be anticipated.

ProfScreen is basically a screening and referral effort. Its vulnerability is the lack of evidence that screening instruments have adequate positive predictive value. None of the available screening measures proved useful in a recent large-scale study. Armed with screening instruments that don’t work particularly well, the health professionals are going to be referring a lot of students for further evaluation and treatment with a lot of false positives. I would anticipate that is already difficult getting a timely appointment for adolescent mental health treatment. These referrals could only further clog the system. Given the performance of the instruments, is not clear that students who screen positive should be given priority over other adolescents with known serious mental health problems.

I am sure a lot of activists and advocates for reducing teen suicide were rooting for screening and referral efforts. A clearer statement of the lack of any evidence in this large-scale study for the effectiveness of such an approach is invaluable and might prevent misdirection of resources.

The effectiveness of QPR would depend on raising the awareness of a school gatekeeper so that the gatekeeper was in a position at a rare, but decisive moment with a student otherwise inclined to life-threatening self harm, and prevent the progression to self harm from occurring.

Observing such a sequence and being able to intervene is going to be an infrequent occurrence. Of course, there’s the further doubtful assumption that suicidality is going to be so obvious that it can be recognized.

The YAM intervention is the only one that actually involves live interaction with students, but it is only 3 hours of role playing, added to lectures and posters. Nice, but I would not think that would have prevented suicide attempts, although maybe it would affect self-reports.

I recall way back when I was asked by NIMH program officers to apply for funding for intervention study of suicide prevention intervention targeting primary care physicians serving older adults. That focus was specifically being required by at the time House Majority Leader Senate Majority Leader Harry Reid (Nevada, Democrat, whose father had died from suicide after an encounter with a primary care physician in which the father being at risk was not uncovered. Senator Reid was demanding that NIMH conduct a clinical trial showing that such strategies could be averted. I told the program officers that I was sorry for the loss of Senator Reid’s father, but that given the rate of suicide even is relatively high risk group of elderly men, a primary care physician with only have a relevant encounter with an elderly, potentially suicidal patient about once every 18 months. It was difficult to conceive of an intervention they could demonstrate effectiveness in reducing suicide under those circumstances. I didn’t believe that suicidal ideation was a suitable surrogate, but the trial that got funded focused on reducing suicidal ideation as its primary outcome. The entire large, multisite trial only had one suicide during the trial and follow-up period, and happened to be someone who was in the intervention group. Not much that can be inferred from that.

What can we learn from SEYLE, given that it cannot define best practices for preventing teen suicide?

Do we undertake a bigger trial and hope the stars align so that one intervention is shown to be better than others? If we don’t get that result, do we resort to hocus pocus multiple imputation methods and insist the result is really there, we just can’t see it?

Of course, some will say we have to do something, we just can’t let more teens die by suicide. So, do we proceed without the benefit  of strong evidence?

I will soon be offering e-books providing skeptical looks at mindfulness and positive psychology, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my new website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites.  Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

 

Will lessons in happiness solve the crisis in child mental health care?

bread and circussRome gave citizens bread and circuses. Is London giving citizens worthless randomized trials of inert interventions to solve the crisis of child mental health care without spending substantially more funds?

The UK  Department for Education (DfE) issued an Expression of Interest [ What’s that? ] for a large randomized trial comparing three preventive mental health interventions for promoting well-being among primary school children.

The three trialed interventions are:

Mindfulness

Mindfulness is the ability to direct attention to experience as it unfolds. It enables those who have learned it to be more able to be with their present experience, and respond more skilfully to whatever is happening. There is some evidence that it may be helpful in reducing anxiety, depressive symptoms and stress and improving wellbeing, attention, focus and cognitive skills.7 We know that mindfulness techniques are currently used by schools, with a range of existing programmes and approaches, but there is limited understanding of whether less intensive approaches work effectively in a school setting. The successful bidder will develop and trial a light touch (10-15 minute) intervention, comprising of simple exercises repeated at regular intervals (e.g. weekly or more than once a week) which provides teachers with materials to guide mindfulness practice e.g. audio tracks or guided exercises.

safety-net-PB-feeling-good-feeling-safe-resource-pack-a42Protective behaviours

Protective behaviours is a practical approach to personal safety, teaching children and young people to recognise early warning signs of not feeling safe and how to recognise where they can get help. It seeks to provide life skills, develop support structures and instil positive help seeking behaviours which can help keep children safe from a range of risks that may impact wellbeing and increase the risk of mental health problems. It is a well-established approach, with indications of ongoing use in schools, however evidence of effectiveness is limited. Some evidence suggests that it is beneficial for those at risk of mental health difficulties as well as the wider population, and it is relatively easy to integrate into the school environment. The successful bidder will develop and trial a light touch protective behaviours intervention which can easily be included in the school day, can be delivered by teachers/school staff to a whole class, with a small amount of training, and which builds on existing programmes and materials.

hands Relaxation and breathing-based techniques

Relaxation and breathing-based techniques and training for schools originated as targeted interventions to assist pupils with anxiety. However, there is emerging use of these approaches universally in primary schools, particularly in the form of short breathing exercises, with some reported increases in concentration, resilience, self-perception positivity and connection with others. There is currently limited evidence of wider use in schools or effectiveness, but there is a theoretical unpinning linking relaxation with improved wellbeing and engagement with learning. The successful bidder will develop and trial a light touch intervention that offers short regular exercises, delivered by teachers in the classroom with minimal training and materials, and which build on existing relation and breathing-based techniques.

Note that the requirement is that all three interventions be delivered in low intensity “light touch” versions, i.e, “easily be included in the school day, can be delivered by teachers/school staff to a whole class, with a small amount of training, and which builds on existing programmes and materials.”

The planned trial is ambitious and large-scale, involving:

  • Recruitment of 100 volunteer primary schools…representing a range of different school types, locations and demographics.
  • Even randomization of schools into one of three arms corresponding to the three interventions, with 33 schools in each arm.
  • Classes in each school evenly randomized to intervention or control group.
  • A small amount of funding would help cover costs of participation and to incentivise full engagement with the trial.:

Final selection of primary and secondary outcomes are left to applicants, but expected to include short measures of

  • Subjective Wellbeing
  • Mental health/psychological wellbeing
  • Engagement with education

The larger context

The expression of interest was a follow-up to “The Shared Society”, UK Prime Minister Theresa May’s recent speech at the Charity Commission. In that speech the Prime Minister identified “the burning injustice of mental illness” and stated:

“This is an historic opportunity to right a wrong, and give people deserving of compassion and support the attention and treatment they deserve. And for all of us to change the way we view mental illness so that striving to improve mental wellbeing is seen as just as natural, positive and good as striving to improve our physical wellbeing.”

However, the Independent noted:

The speech however barely announces any extra cash to improve underfunded services – with just an extra £15m expected to be pledged for creating “places of safety”. This amounts to about £23,000 per parliamentary constituency.

Research conducted by the Education Policy Institute Independent Commission on Children and Young People’s Mental Health in November found that a quarter of young people seeking mental health care are turned away by specialist services because of a lack of resources. Waiting times for treatment in many areas are also incredibly long.

The House of Commons Public Accounts Committee said in September that it was “sceptical” about the Government’s attempt to improve mental health services without a significant amount of extra cash.

Praise for the speech

Nonetheless, the Independent reported praise to the Prime Minister’s speech:

Paul Farmer, chief executive of Mind, the mental health charity, said it was good that the Prime Minister was talking about mental health.

“It’s important to see the Prime Minister talking about mental health and shows how far we have come in bringing the experiences of people with mental health problems up the political agenda,” he said.

“Mental health should be at the heart of government, and at the heart of society and communities – it’s been on the periphery for far too long.”

He said he welcomed the focus on prevention in schools and workplaces and support for people in crisis.

Sir Ian Cheshire, chairman of the Heads Together Campaign described the Prime Minister’s announcements as “extremely important and very welcome”.

“They show both a willingness to tackle the broad challenge of mental health support and a practical grasp of how to start making a real difference,” he said.

As I noted in another blog post, the Heads Together Campaign is an initiative of the Royals.

Paul Farmer, chief executive of Mind, the mental health charity, said it was good that the Prime Minister was talking about mental health.

“It’s important to see the Prime Minister talking about mental health and shows how far we have come in bringing the experiences of people with mental health problems up the political agenda,” he said.

“Mental health should be at the heart of government, and at the heart of society and communities – it’s been on the periphery for far too long.”

He said he welcomed the focus on prevention in schools and workplaces and support for people in crisis.

Sir Ian Cheshire, chairman of the Heads Together Campaign described the Prime Minister’s announcements as “extremely important and very welcome”.

“They show both a willingness to tackle the broad challenge of mental health support and a practical grasp of how to start making a real difference,” he said.

Praise for the interventions that were selected for evaluation

 An article in The Guardian reported praise for the interventions that were selected for evaluation:

Laura Henry, an early years consultant and Ofsted inspector, said the trials could save the government billions in social care and housing costs down the line. “I think it’s an excellent idea,” she said. “Over the last decade there has been a massive push to academia, results and school league tables and children’s personal social development has been left behind.

“A holistic approach is needed and children should be able to self-regulate their own behaviour.”

Henry, a former teacher whose elder son is on the autistic spectrum, said specially trained teachers should help with grieving techniques and that any questions about bullying and pupils’ friends needed to be sensitive.

“It’s absolutely the best way to spend DfE money,” she said. “It will save x amount of money in social care when they are adults.”

And:

The mindfulness trial was welcomed by the educational pioneer Sir Anthony Seldon, who was pooh-poohed when he brought in such classes while master of the private school Wellington College. He said: “It was negligent of government [in the past] to have this unintelligent response to wellbeing, saying this was la-la land and psychobabble. We have a crisis in mental health which is reducible now that government is beginning to take seriously the right interventions to look after the wellbeing of young people.”

Professor Alan Smithers, of the University of Buckingham, where Seldon is vice-chancellor, was more sceptical. He said: “It is good the government is having a trial and not rushing in. There are so many demands on resources for schools that it is important we know that mindfulness lessons work. “There are many calls on school funding: the need for teachers, the squeeze on budgets and school buildings.”

Lord Layard, Britain’s “happiness guru”, and Lord O’Donnell, the former cabinet secretary, will meet the government this month to discuss how to enable schools to measure children’s wellbeing as a guide to performance. They want schools to give similar weight to children’s happiness as to their academic results. Under their proposals, schools would be measured on whether pupils’ happiness improved or declined. Children would fill in a questionnaire asking, among other things, whether “I have at least one good friend”; “other people generally like me”; “other people pick on me or bully me”; and “I would rather be alone than with others”.

Pupils’ scores would be confidential, but could be used to alert the school to serious difficulties. NHS workers would provide psychological treatment to children in schools at short notice before they became so ill that they qualified for admission to mental health services.

The interventions are unlikely to improve mental health comes, even self-reported well-being, and may prove harmful.

I dare you to be positive Tssk! The UK has some talented mental health services researchers. Why aren’t we hearing their collective voices of outrage about a useless trial squandering millions of pounds, potentially harming schools and students, and mainly serving to distract from the government’s lack of action to correct the underfunding of both mental health care for children and the school systems?

Instead, we have some self-proclaimed authorities waxing enthusiastically. As a group, they are lacking in mental health training and serve to benefit immensely from these initiatives. Journalists should get them out of the picture or at least better reveal the conflicts of interest and balance their commentary with comments that are more evidence driven.

Even when delivered with full intensity, the interventions lack evidence of effectiveness needed to justify a large-scale trial. Yet The Expression of Interest specifies that they be delivered in a lite form – only a few minutes a week . This is Unlikely to improve the measured outcomes or impact on effective use of already scarce child mental health services with an acceptably long wait times.

Funding the trial is a poor substitute for better funding for mental health services and schools. Yet politicians and policymakers can point to them and argue that the UK is conducting the research desperately needed to address these issues and so we need to be patient.

I’m not sure we should consider these trials as serious attempts to contribute to the mental health services literature. Selection of the particular interventions to be trialed seems to be political and tied to what is already being done in some schools. Their existing implementation likely reflects vested interests that undoubtedly influenced the selection for trialing and hope to benefit financially from the opportunities it will provide. I don’t think that the mere fact that interventions are already in use justifies an ambitious and expensive evaluation of them unless there is further evidence that they are likely to be effective.

The Expression of Interest cites one review of mindfulness studies. I looked it up and it is unusually candid in indicating the limitations in quality and quantity of relevant studies that mindfulness training can affect such outcomes. The review stands in sharp contrast to the unbalanced and prematurely enthusiastic Mindful Nation UK report.

We should have serious concerns about the lack of evidence that Protective Behaviours could have any effect on the outcomes selected to evaluate the programs. Conceivably, it could do some harm to at risk children. Getting children to disclose bullying and frank abuse at home and school can only aggravate these problem and invite retaliation if effective intervention is not available to address these problems. I would be curious to know the extent to which primary school teachers are already aware of such problems but lack the tools or time to address them.

Basically, Protective Behaviours is a kind of screening program facilitated by encouragement to disclosed. Such programs can prove ineffective if they do not occur in a system prepared to quickly offer affective interventions. Such screening programs can compete for scarce resources that would otherwise be used to deal with already known problems requiring more intensive and focused intervention.

There is the precedent of GPs screening women for domestic abuse. Routine screening seemed to address a documented ignoring of the problem. However, the World Health Organization (WHO) withdrew the recommendation because of lack of any evidence that improved health outcomes for women and summoned consistent evidence that at least some women were harmed by ineffectual interventions that heighten the abuse that they were receiving.

The breathing and relaxation exercises might conceivably be a nonspecific control condition, except that all of the inventions are untried, lacking in evidence, and delivered in such a low intensity that they themselves are best nonspecific control conditions. I think it’s inconceivable that meaningful differences will be demonstrated among the three interventions. At best, the trials can conclude that they are equally effective or not effective at all. The question whether these interventions are better than other active interventions or other deployments of scarce resources left unaddressed.

eBook_PositivePsychology_345x550I will soon be offering e-books providing skeptical looks at mindfulness and positive psychology, as well as scientific writing courses on the web as I have been doing face-to-face for almost a decade.

Sign up at my new website to get advance notice of the forthcoming e-books and web courses, as well as upcoming blog posts at this and other blog sites.  Get advance notice of forthcoming e-books and web courses. Lots to see at CoyneoftheRealm.com.

Complex PTSD, STAIR, Social Ecology and lessons learned from 9/11- a conversation with Dr. Marylene Cloitre

Dr. Marylene Cloitre is the Associate Director of Research of the National Center for PTSD Dissemination and Training Division and a research Professor of Psychiatry and Child and Adolescent Psychiatry at the New York University, Langone Medical Center in New York City. She is a recipient of several honors related to her service in New York City following 9-11 and was an advisory committee member for the National September 11 Memorial Museum. She has specific expertise in complex PTSD and for the development and dissemination of STAIR (Skills Training in Affective and Interpersonal Regulation), a psychological therapy designed to help survivors of trauma.

Dr. Jain: What exactly is complex PTSD?

Dr. Cloitre:
Complex PTSD has a very long history, really pushed primarily by clinicians who looked at their patients and thought there’s something more going on here than PTSD.
In DSM-4, complex PTSD was recognized in the additional features where there is a mix of problems related to emotion regulation, self-concept and interpersonal relationships. After that, there was really no funding around investigating this further and the research for it has been spotty and it was sort of dying on the vine.

But with the development of a new version of ICD-11, there was an opportunity really to refresh consideration about complex PTSD. I was part of a work group that started in 2012, we looked at the literature and thought there seems to be enough data to support two different forms of PTSD , the classic fear circuitry disturbance and then this more general kind of disturbance in these three core areas of emotion regulation, self-concept and interpersonal relationships.

We proposed that there should be two distinct disorders: PTSD and complex PTSD and it looks like it’s been accepted and it will part of the ICD-11 coming out in the 2018.

Since the initial proposal, I’ve been working with many people, mostly Europeans, where ICD is more prominent than in the United States and there are now about nine published papers providing supporting evidence that these two distinct disorders.

Dr. Jain:
Can you summarize in which ways they’re distinct? So on a clinical level what would you see in complex PTSD?

Dr. Cloitre: Mostly we’ve been looking at latent class analysis which is a newish kind of data analytic technique which looks at how people cluster together and you look at their symptom profile. There are a group of people who very distinctly have PTSD in terms of re-experiencing, avoidance and hyperarousal and then they’re fine on everything else. Then you have another group of people who have these problems as well as problems in these three other areas.And then there are another group of people who, despite exposure to trauma, do fairly well.

What we’ve been seeing are these three groups in clinical populations as well as in community populations and adults as well as in children.

Overall, these latent class analyses are really showing that people cluster together in very distinctly different ways. I think the important thing about this distinction is, what’s next? Perhaps there are different clinical interventions that we want to look at to maximize good outcome. Some people may do very well with exposure therapy. I would say the PTSD clustered folks will do very well and have optimal outcome because that’s all that bothers them. For the other folks, they have a lot of other problems that really contribute to their functional impairment.

For me as a clinician as well as a researcher, I’ve always been worried not so much about the diagnosis of the person in front of me but about how well they’re functioning in the world. What I have noticed is you can get rid of the PTSD symptoms, for people with complex PTSD, but they’re still very impaired.
My motivation for thinking about a different diagnosis and different treatment is to identify these other problems and then to provide interventions, that target these other problems, for the goal of improving our day to day life functioning. If you don’t have ability to relate well to people because you mistrust them or are highly avoidant or if you think poorly about yourself these are huge issues then we need to target these issues in treatment.

Dr. Jain
Have you noticed that different types of trauma contribute to PTSD v complex PTSD?

Dr. Cloitre Yes, it does and it kind of makes sense that people who have had sustained and repeated trauma (e.g. multiple and sustained trauma doing childhood) are the ones who have complex PTSD.

Dr. Jain: Can you tell us a little bit about the fundamental philosophy that drove you to come up with STAIR and what evidence is there for it’s effectiveness?

Dr. Cloitre I came to develop STAIR as a result of paying attention to what my patients were telling me they wanted help with, that was the driving force. It wasn’t a theoretical model, it was that patients came and said,” I’m really having problems with my relationships and that’s what I need help with” or “I really have problems with my moods and I need help with that”.

So, I thought, why don’t we start there? That is why I developed STAIR and developed it as a sequence therapy while respecting the importance of getting into the trauma and doing exposure based work, I also wanted to engage the patient and respect their presented needs. That what it’s all about for me.
Overtime I saw a secondary benefit, that an improved sense of self and improved emotion regulation could actually impact the value of exposure therapy in a positive way.

In my mind, the real question is: What kind of treatments work best for whom? That is the question. There will be some people for whom going straight to exposure therapy is the most effective and efficient way to get them functioning and they’ll be happy with three or four sessions, just like some 9/11 survivors I saw. They only needed three or four sessions.

Other people might do better with combination therapies .

Dr. Jain The studies that you’ve done with STAIR can you summarize the populations you have used it for?

Dr. Cloitre: I began using STAIR + exposure with the population I thought would most need it which is people with histories of childhood abuse. In fact, our data show that the combination of skills training, plus exposure was significantly better than skills alone or exposure alone. So that’s very important. It also reduced dropout very significantly as compared to exposure, which is a continuing problem with exposure therapy especially for this population

Dr. Jain Can you speak to the social ecology/social bonds and PTSD, what the research world can tell us about the social dimensions of PTSD and how we can apply this to returning military members and veterans?

Dr. Cloitre: I think that social support is critical to the recovery of people who have been exposed to trauma and who are vulnerable to symptoms .We have enough studies showing that it’s the critical determinant of return to health.

I think we have done a very poor job of translating this observation into something meaningful for returning veterans. There is general attention that families are part of the solution and communities are part of the solution but it is vague –there isn’t really a sense of what are we going to do about it.

I think these wars (Afghanistan and Iraq) are very different than Vietnam, that’s where soldiers came back and they were called baby killers and had tomatoes and garbage thrown at them. You can really understand why a vulnerable person would spiral downwards into pretty significant PTSD and substance abuse.

I think we need to be more thoughtful and engage veterans in discussions about what’s most helpful in the reintegration progress, because there are probably really explicit things like, being welcomed home, but also very subtle things that we haven’t figured out about the experience.
I think on a community or family level, there’s a general awareness but we haven’t really gotten clear thinking or effective about what to do. I think that’s our next step. The parade and the welcome home signs are not enough.

I’ll give an example of what I witnessed after 9/11. The community around survivors feels awkward and doesn’t know what to do, so they start moving away. Combine this with the survivor who is sad or being irritable and so not the most attractive person to engage with. I say to patients sometimes, it’s a really unfair and unfortunate circumstance, that in a way, not only are you suffering but you’re also kind of responsible for making people around you comfortable with you.

I used to do STAIR because patients ask for it and also I thought,” oh well some people never had these social skills in the first place, which is why they are vulnerable with PTSD” but then I noticed that STAIR was useful for everybody with PTSD because I think the traumatized patient has an unfair burden to actually reach out to people in a process of re-engagement because the community and the family is confused. Others, strangers or say employers are scared. So they have to kind of compensate for the discomfort of others, which is asking a lot.

I think in our therapies we can say look, it’s not fair, but people feel uncomfortable around the veteran. They don’t know how to act and in a way you not only have to educate yourself about your circumstance but, in the end, educate others.

Dr. Jain Survivor perception of social support really matters. If you take a group of disaster survivors, we may feel well we’re doing this for them and we’re doing that for them but if the survivors, for whatever reason, don’t perceive it as being helpful it doesn’t matter. When I think about marginalized populations in our society, I don’t think to communicate to others about how to help you or how to support you is that simple.

Dr. Cloitre It’s very complicated because it is a dynamic. I think we need to talk to trauma survivors and understand what their needs are so that the community can respond effectively and be a match. Not everybody wants the same thing. That’s the real challenge. I think if survivors can be a little bit more compassionate, not only towards themselves for what they have been through but to others who are trying to communicate with them and failing.

Dr. Jain That can be hard to do when you’re hurting. The social ecology of PTSD is really important but it’s really complicated and we are not there, in terms of harnessing social ecology to improve lives.

Dr. Cloitre No. I think we’re just groping around in the dark, in a room that says the social ecology of PTSD is important. We don’t know how to translate that observation into actionable plans either in our individual therapies or in our family therapies and then in our community actions or policies.
But I do think that, in the individual therapy, recognizing the importance of trying to enhance perception of support where they’re real. Secondly, recognizing the burden that they have that’s unfair and try to enhance skills for communicating with people. Thirdly, having compassion for people who are out there who are trying to communicate but failing.
I have had a lot of patients who come, into therapy, and say,
” This is so ridiculous. They’re saying stupid things to me”.
And, I say,
“well at least they’re trying”
I think it’s important for the affected community to have the voice and take leadership, instead of people kind of smothering them with social support that they may or may not need.

Dr. Jain
I know you’re a native New Yorker and you provided a lot of service to New York City following 9/11. Can you speak about that work? And in particular what I’m really interested in is that body of research that emerged after 9/11 because I feel like that has helped us understand so much about disaster related PTSD.

Dr. Cloitre We found out was most people are very resilient. We were able to get prevalence rates of PTSD following 9/11, that in of itself was very important. I think that’s the strongest research that came out.

I think on a social level it broke open awareness, in this country and maybe globally, about the impact of trauma and about PTSD because it came with very little shame or guilt.
Some people say what was so different about 9/11? Well, because it happened to the most powerful country and the most powerful city then if it could happen to them it could happen anywhere. That was the response, there was not this marginalization, ”Well this is a victim circumstance and it couldn’t happen to me and they must have done something to bring it on themselves”.
There was a hugely different response and that was so key to the shift in recognition of the diagnosis of PTSD which then led to more general research about it. I think that that was huge.
Before 9/11, I would say I do research in PTSD and people would say, what is that? Now I say I do research in PTSD, not a single person ever asks me what that is. I mean I’m sure they don’t really know what it is but they never looked confused. It’s a term that is now part and parcel of American society.
9/11 revolutionized the awareness of PTSD and also the acceptability of adverse effects, as a result of trauma. There was new knowledge gained and also just a transformation in awareness that was national and probably global because the impact it had and the ripple effects on another countries.
I think those are the two main things.
I don’t think it’s really done very much for our thinking about treatment. I think we continue to do some of our central treatments and we didn’t get too far in really advancing or diversifying.
For me personally, I learned a lot about the diversity of kinds of trauma survivors. Very different people, very different reactions.
I think probably the other important academic or scholarly advance, was in the recognition of this blend of loss and trauma and how they come together. That people’s responses to death ,under circumstances of unexpected and violent death, has also advanced. In fact now ICD-11 there will be a traumatic grief diagnosis, which I think has moved forward because of 9/11. That’s pretty big.

The Prescription Pain Pill Epidemic: A Conversation with Dr. Anna Lembke

back-pain-in-seniors-helped-with-mindfulness-300x200manypills
My colleague, Dr. Anna Lembke is the Program Director for the Stanford University Addiction Medicine Fellowship, and Chief of the Stanford Addiction Medicine Dual Diagnosis Clinic. She is the author of a newly released book on the prescription pain pill epidemic: “Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop” (Johns Hopkins University Press, October 2016).

I spoke with her recently about the scope of this public health tragedy, how we got here and what we need to do about it.

Dr. Jain: About 15-20 years ago American medicine underwent a radical cultural shift in its attitude towards pain, a shift that ultimately culminated in a public health tragedy. Can you comment on factors that contributed to that shift occurring in the first place?
Dr. Lembke: Sure. So the first thing that happened (and it was really more like the early 1980’s when this shift occurred) was that there were more people with daily pain. Overall, our population is getting healthier, but we also have more people with more pain conditions. No one really knows exactly the reason for that, but it probably involves people living longer with chronic illnesses, and more people getting surgical interventions for all types of condition. Any time you cut into the body, you cut across the nerves and you create the potential for some kind of neuropathic pain problem.
The other thing that happened in the 1980’s was the beginning of the hospice movement. This movement helped people at the very end of life (the last month to weeks to days of their lives) to transition to death in a more humane and peaceful way. There was growing recognition that we weren’t doing enough for people at the end of life. As part of this movement, many doctors began advocating for using opioids more liberally at the end of life.
There was also a broader cultural shift regarding the meaning of pain. Prior to 1900 people viewed pain as having positive value: “what does not kill you makes you stronger” or “after darkness comes the dawn”. There were spiritual and biblical connotations and positive meaning in enduring suffering. What arose, through the 20th century, was this idea that pain is actually something that you need to avoid because pain itself can lead to a psychic scar that contributes to future pain. Today, not only is pain painful, but pain begets future pain. By the 1990’s, pain was viewed as a very bad thing and something that had to be eliminated at all cost.
Growing numbers of people experiencing chronic pain, the influence of the hospice movement, and a shifting paradigm about the meaning and consequences of experiencing pain, led to increased pressures within medicine for doctors to prescribe more opioids. This shift was a departure from prior practice, when doctors were loathe to prescribe opioids, for fear of creating addiction, except in cases of severe trauma, cases involving surgery, or cases of the very end of life.
Dr. Jain: The American Pain Society had introduced “pain as the 5th vital sign,” a term which suggested physicians, who were not taking their patients’ pain seriously, were being neglectful. What are your thoughts about this term?
Dr. Lembke: “Pain is the 5th vital sign” is a slogan. It’s kind of an advertising campaign. We use slogans all the time in medicine, many times to good effect, to raise awareness both inside and outside the profession about a variety of medical issues. The reason that “pain is the 5th vital sign” went awry, however, has to do with the ways in which professional medical societies, like the American Pain Society, and so-called “academic thought leaders”, began to collaborate and cooperate with the pharmaceutical industry. That’s where “pain is the 5th vital sign” went from being an awareness campaign to being a brand for a product, namely prescription opioids.
So the good intentions in the early 1980’s turned into something really quite nefarious when it came to the way that we started treating patients. To really understand what happened, you have to understand the ways in which the pharmaceutical industry, particularly the makers of opioid analgesics, covertly collaborated with various institutions within what I’ll call Big Medicine, in order to promote opioid prescribing.
Dr. Jain: So by Big Medicine what do you mean?
Dr. Lembke: I mean the Federation of State Medical Boards, The Joint Commission (JACHO), pain societies, academic thought leaders, and the Food and Drug Administration (FDA). These are the leading organizations within medicine whose job it is to guide and regulate medicine. None of these are pharmaceutical companies per se, but what happened around opioid pain pills was that Big Pharma infiltrated these various organizations in order to use false evidence to encourage physicians to prescribe more opioids. They used a Trojan Horse approach.. They didn’t come out and say we want you to prescribe more opioids because we’re Big Pharma and we want to make more money, instead what they said was we want you to prescribe more opioids because that’s what the scientific evidence supports.
The story of how they did that is really fascinating. Let’s take The Joint Commission (JACHO) as an example. In 1996, when oxycontin was introduced to the market, JACHO launched a nationwide pain management educational program where they sold educational materials to hospitals, which they acquired for free from Purdue Pharma. These materials included statements which we now know to be patently false. JACHO sold the Purdue Pharma videos and literature on pain to hospitals.
These educational materials perpetuated four myths about opioid prescribing. The first myth was that opioids work for chronic pain. We have no evidence to support that. The second was that no dose is too high. So if your patient responds to opioids initially and then develops tolerance, just keep going up. And that’s how we got patients on astronomical amounts of opioids. The third myth was about pseudo addiction. If you have a patient who appears to be demonstrating drug seeking behavior, they’re not addicted. They just need more pain meds. The fourth and most insidious myth was that there is a halo effect when opioids are prescribed by a doctor, that is, they’re not addictive as long as they’re being used to treat pain.
So getting back to JACHO, not only did they use material propagating myths about the use of opioids to treat pain, but they also did something that was very insidious and, ultimately, very bad for patients. They made pain a “quality measure”. By The Joint Commission’s own definition of a quality measure, it must be something that you can count. So what they did was they created this visual analog scale, also known as the “pain scale”. The scale consists of numbers from one to ten describing pain, with sad and happy faces to match. JAHCO told doctors they needed to use this pain scale in order to assess a patients’ pain. What we know today is that this pain scale has not led to improved treatment or functional outcomes for patients with pain. The only thing that it has been correlated with is increased opioid prescribing.
This sort of stealth maneuver by Big Pharma to use false evidence or pseudo-science to infiltrate academic medicine, regulatory agencies, and academic societies in order to promote more opioid prescribing: that’s an enduring theme throughout any analysis of this epidemic.
Dr. Jain: Can you comment specifically on the breadth and depth of the opioid epidemic in the US? What were the key factors involved?
Dr. Lembke: Drug overdose is now the leading cause of accidental death in this country, exceeding death due to motor vehicle accidents or firearms. Driving this statistic is opioid deaths and driving opioid deaths is opioid pain prescription deaths, which in turn correlates with excessive opioid prescribing. There are more than 16,000 deaths per year due to prescription opioid overdoses.
What’s really important to understand is that an opioid overdose is not a suicide attempt. The vast majority of these people are not trying to kill themselves, and many of them are not even taking the medication in excess. They’re often taking it as prescribed, but over time are developing a low grade hypoxia. They may get a minor cold, let’s say a pneumonia, then they’ll take the pills and they’ll fall asleep and won’t wake up again because their tolerance to the euphorigenic and pain effects of the opioids is very robust, but their tolerance to the respiratory suppressant effect doesn’t keep pace with that. You can feel like you need to take more in order to eliminate the pain, but at the same time the opioid is suppressing your respiratory drive, so you eventually become hypoxemic and can’t breathe anymore and just fall into a gradual sleep that way.
There are more than two million people today who are addicted to prescription opioids. So not only is there this horrible risk of accidental death, but there’s obviously the risk of addiction. We also have heroin overdose deaths and heroin addiction on the rise, most likely on the coattails of the prescription opioids epidemic, driven largely by young people who don’t have reservations about switching from pills to heroin..
Dr. Jain: I was curious about meds like oxycontin, vicodin, and percocet. Are they somehow more addictive than other opioid pills?
Dr. Lembke: All opioids are addictive, especially if you’re dealing with an opioid naive person. But it is certainly true that some of the opioids are more addictive than others because of pharmacology. Let’s consider oxycontin. The major ingredient in oxycontin is oxycodone. Oxycodone is a very potent synthetic opioid. When Purdue formulated it into oxycontin, what they wanted to create was a twice daily pain medication for cancer patients. So they put this hard shell on a huge 12 hours worth of oxycodone. That hard shell was intended to release oxycodone slowly over the course of the day. But what people discovered is that if they chewed the oxycontin and broke that hard shell, then they got a whole day’s worth of very potent oxycodone at once. With that came the typical rush that people who are addicted to opioids describe, as well as this long and powerful and sustained high. So that is why oxycontin was really at the center of the prescription opioid epidemic. It basically was more addictive because of the quantity and potency once that hard shell was cracked.
Dr. Jain: So has the epidemic plateaued? And if so, why?
Dr. Lembke: The last year for which we have CDC data is 2014, when there were more prescription opioid-related deaths, and more opioid prescriptions written by doctors, than in any year prior. This is remarkable when you think that by 2014, there was already wide-spread awareness of the problem. Yet doctors were not changing their prescribing habits, and patients were dying in record numbers.
I’m really looking forward to the next round of CDC data to come out and tell us what 2015 looked like. I do not believe we have reached the end or even the waning days of this epidemic. Doctors continue to write over 250 million opioid prescriptions annually, a mere fraction of what was written three decades ago.
Also, the millions of people who have been taking opioids for years are not easily weaned from opioids.. They now have neuroadaptive changes in their brains which are very hard to undo. I can tell you from clinical experience that even when I see patients motivated to get off of their prescription opioids, it can take weeks, months, and even years to make that happen.
So I don’t think that the epidemic has plateaued, and this is one of the major points that I try to make in my book. The prescription drug epidemic is the canary in the coal mine. It speaks to deeper problems within medicine. Doctors get reimbursed for prescribing a pill or doing a procedure, but not for talking to our patients and educating them. That’s a problem. The turmoil in the insurance system we can’t even establish long term relationships with our patients. So as a proxy for real healing and attachment, we prescribe opioids. ! Those kinds of endemic issues within medicine have not changed, and until they do, I believe this prescription drug problem will continue unabated.

Talking back to “Talking Therapy Can Literally Rewire the Brain”

This edition of Mind the Brain was prompted by an article in Huffington Post, Talking Therapy Can Literally Rewire the Brain.

The title is lame on two counts: “literally” and any suggestion that psychotherapy does something distinctive to the brain, much less “rewiring” it.

I gave the journalist the benefit of a doubt and assumed that the editor applied the title to the article without having the journalist’s permission. I know from talking to journalists, that’s a source of enormous frustration when it happens. But in this instance, the odd title came directly from a press release from King’s College London  (Study reveals for first time that talking therapy changes the brain’s wiring)which concerned an article published in the  Nature Publishing journal, Translational Psychiatry 

Hmm, authors from King’s College and published in a Nature journal suggest this might be a serious piece of science worth giving a closer look. In the end, I was reminded not to make too much of authors’ affiliation and where they publish.

I poked fun on Twitter at the title of the Huffington Post article.

literally twitter postThe retweets and likes drifted into a discussion of neuroscientists saying they really didn’t know much about the brain. Somebody threw in a link to an excellent short YouTube video by NeuroSkeptic on that topic that I highly recommend.

Anyway, I found serious problems with the Huffington Post article that should have been sufficient to stop with it.  Nonetheless, I proceeded and the problems got compounded when I turned to the press release with its direct quotes from the author. I wasn’t long into the Translational Psychiatry article before I appreciated that its abstract was misleading in claiming that there were 22 patients in the study. That is a small number, but if the abstract had stated the actual number, which was 15 patients, readers would have been warned not to take too seriously complicated multivariate statistics that were coming up.

How did a prestigious journal like Translational Psychiatry allow authors to misrepresent their sample size? I would shortly be even more puzzled about why the article was even published in Translational Psychiatry, although I formed unflattering some hypotheses about that journal. I’ll end with those hypotheses.

Talking To A Therapist Can Literally Rewire Your Brain (Huffington Post)

The opening sentence would raise the skepticism of informed reader:

If you can change the way you think, you can change your brain.

If I accept that statement, it’s going be with a broad stretching of it to meaninglessness. “If you can change the way you think..” covers lots of territory. If the statement  is going to remain the correct, then the phrase “change your brain” is going to have to be similarly broad. If the journalist wants to make a big deal of this claim, she would have to concede that reading my blog changes her brain.

That’s the conclusion of a new study, which finds that challenging unhealthy thought patterns with the help of a therapist can lead to measurable changes in brain activity.

Okay, we now know that at least a specific study with brain measurements is being discussed.

But then

In the study, psychologists at King’s College London show that Cognitive Behavioral Therapy strengthens certain healthy brain connections in patients with psychosis. This heightened connectivity was associated with long-term reductions in psychotic symptoms and recovery eight years later, according to the findings, which were published online Tuesday in the journal Translational Psychiatry.

“Over six months of therapy, we found that connections between certain key brain regions became stronger,” Dr. Liam Mason, a clinical psychologist at King’s College and the study’s lead author, told The Huffington Post in an email. “What we are really excited about here is that these stronger connections lead to long-term improvements in people’s symptoms and overall recovery across the eight years that we followed them up.”

A lot of skepticism is being raised. The article seems to be claiming that changes in brain function observed in the short term with cognitive behavior therapy for psychosis [CBTp] were associated with long-term changes over the extraordinary eight years.

The problems with this? First CBTp is not known to be particularly effective, even in the short term. Second, this a lot heterogeneity under the umbrella of “psychosis,” but in eight years, a person who has had that label appropriately applied will have a lot of experiences: recovery and relapse, and certainly other mental health treatments. How in all that noise and confusion can a signal detected that a psychotherapy that isn’t particularly effective explains any long-term improvement?

[Skeptical about my claim that CBTp is ineffective? See Effect of a missing clinical trial on what cochrane-slide-2we think about cognitive behavior therapy  and the slides about Cochrane reviews from a longer Powerpoint presentation.]

Any discussion of how CBT works and what long-term improvements it predicts has get past considerable evidence CBT doesn’t work any better than nonspecific supportive treatments. Without short-term effects, how can have long-term effects?

cbt cochrane 1

 

 

 

There is no acknowledgment in the Huffington Post article of the lack of efficacy of CBTp. Instead, we have a strong assumption that CBTp works and that the scientific paper under discussion is important because it shows that CBTp strongly works, with observable long-term effects.

The journalist claims that the present scientific paper builds on earlier one:

In the original study, patients with psychosis underwent brain imaging both before and after three months of CBT. The patients’ brains were scanned while they looked at images of faces expressing different emotions. After undergoing CBT, the patients showed marked increases in brain activity. Specifically, the brain scans showed heightened connections between the amygdala, the brain region involved in fear and threat processing, and the prefrontal cortex, which is responsible for reasoning and thinking rationally ― suggesting that the patients had an improved ability to accurately perceive social threats.

“We think that this change may be important in allowing people to consciously re-think immediate emotional reactions,” Mason said.

Readers can click back to my earlier blog post, Sex and the single amygdala: A tale almost saved by a peek at the data. The same experimental paradigms was being used to study the amygdala in terms of activity predicted changes in the number of sexual partners over time. In that particular study, p-hacking, and significance chasing and selective reporting were used by the authors to create the illusion of important findings. If you visit my blog post, check out the comments that ridiculed the study, including from two very bright undergraduates.

We don’t need to deter into a technical discussion of functional magnetic resonance imaging (fMRI) data to make a couple of points. The authors of the present study used a rather standard experimental paradigm and the focus on amygdala concerned some quite nonspecific psychological processes.

The authors of the present study soon concede this:

There’s a good chance that similar brain changes also occur in CBT patients being treated for anxiety and depression, Mason said.

“There is research showing that some of the same connections may also be strengthened by CBT for anxiety disorders,” he explained.

But wait: isn’t the lead author also saying in the Huffington Post article and the title of the press release as well that this is a first-time study ever?

For the present purposes, we need only to dispense with any notion that we’re talking about a rewiring of the brain known to be specifically associated with psychosis or even that there is reason to expect that such “rewiring” could be expected to predict long-term outcome of psychosis.

Reading further, we find that the study only involved following 15 patients from a larger study, un like the misleading abstract that claims 22.

Seriously, are we being asked to get worked up about a fMRI study with only 15 patients? Yup.

The researchers found that heightened connectivity between the amygdala and prefrontal cortex was associated with long-term recovery from psychosis. The exciting finding marks the first time scientists have been able to demonstrate that brain changes resulting from psychotherapy may be responsible for long-term recovery from mental illness.

What is going on here? The journalist next gives free reign to the lead author to climb up on a soap box and proclaim his agenda behind all of these claim:

The findings challenge the “brain bias” in psychiatry, an institutional focus on physical brain differences over psychological factors in mental illness. Thanks to this common bias, many psychiatrists are prone to recommending medication to their clients rather than psychological treatments such as CBT.

But medication has been proved to be effective with psychosis, CBTp has not.

“Psychological therapy can lead to changes in the mechanics of the brain,” Mason said. “This is especially important for conditions like psychosis which have traditionally been viewed as ‘brain diseases’ that require medication or even surgery.”

“Mechanics of the brain”?  Now we have escalated from ‘literally rewiring’ to “changes in the mechanics.” Dude, we are talking about a fMRI study. Do you think we have been transported to an auto repair shop?

“This research challenges the notion that the existence of physical brain differences in mental health disorders somehow makes psychological factors or treatments less important,” Mason added in a statement.

Clicking on the link takes one to Science Daily article which churnals (plagiarizes) a press release from Kings College,  London.

The Press Release: Study reveals for first time that talking therapy changes the brain’s wiring

There is not much in this press release that is not been regurgitated in the Huffington Post article except for some more soapbox preaching:

Unfortunately, previous research has shown that this ‘brain bias’ can make clinicians more likely to recommend medication but not psychological therapies. This is especially important in psychosis, where only one in ten people who could benefit from psychological therapies are offered them.”

But CBT, the most evaluated psychotherapy for psychosis has not been shown to be effective, by itself. Sure, patients suffering from psychosis need a lot of support, efforts to maintain positive expectations, and opportunities to talk about their experience. But in direct comparisons between such support provided by professionals or by peers, CBT has not been shown to be more effective.

The researchers now hope to confirm the results in a larger sample, and to identify the changes in the brain that differentiate people who experience improvements with CBT from those who do not. Ultimately, the results could lead to better, and more tailored, treatments for psychosis, by allowing researchers to understand what determines whether psychological therapies are effective.

Sure, we are to give a high priority to examining the mechanism by which CBT, which has not been proven effective, works its magic.

Translational Psychiatry: Brain connectivity changes occurring following cognitive behavioural therapy for psychosis predict long-term recovery

[This will be a quick tour, only highlighting some of the many problems that I found. I welcome readers probing the open access article and posting what they find.]

The Abstract misrepresents the study as having 22 patients, when it actually only had data from 15.

The Introduction largely focuses on previous work of the author group. If you bothered to check, none of it involves randomized trials, despite making claims of efficacy for CBTp. No reference is made to a large body of literature finding a lack of effectiveness for CBTp. In particular, there is no mention of the Cochrane reviews.

A close reading of the Methods indicates that what are claimed to be “objective clinical outcomes” are actually unblinded, retrospective ratings of case notes by the two raters including the first author. Unblinded ratings, particularly by an investigator, are an important source of bias in studies of CBTp and lead to exaggerated estimates of outcome.

An additional measure with inadequate validation was obtained at 7 to 8 year follow-up:

Questionnaire about the Process of Recovery (QPR,31), a service-user led instrument that follows theoretical models of recovery and provides a measure of constructs such as hope, empowerment, confidence, connectedness to others.

All patients came from clinical studies conducted by the author group that did not involve randomization. Rather, assignment to CBTp was based on provider identifying patients “deemed as suitable for CBTp.“ There is considerable risk of bias if it patient data is treated if it arose in a randomized trial. I previously raised issues about the inadequacy of routine care provided to psychotic patients both in terms of its clinical adequacy and an meaningfulness as a control/comparison group because of its lack of nonspecific factors.

All patients assigned to CBTp were receiving medication and other services. A table revealed that receipt of other services was strongly correlated with recovery status. Yet the authors are attempting to attribute any recovery across the eight years to the brief course of CBTp at the beginning. Obviously, the study is hopelessly confounded and no valid inferences possible. This alone should have gotten this study rejected.

There were data available from control subjects at follow-up, including fMRI data, but they were excluded from the present report. That is unfortunate, because these data would allow at least minimal evaluation of whether CBTp versus remaining in routine care had any difference in outcomes and – importantly – if the fMRI data similarly predicted the outcomes of patients not receiving CBTp.

Data Analysis indicates one tailed, multivariate statistical tests that are quite inappropriate and essentially meaningless with such a small data set. Bonferonni corrections, which were inconsistently applied, offer no salvation.

With such small samples and multivariate statistics, a focus on p-values is inappropriate, but the authors do just that and report p<.04 and p<.06, the latter being treated as significant. The hypothesis that this might represent significance chasing is supported when supplementary data tables are examined. When I showed them to a neuroscientist, his first response was that they were painful to look at.

longitudinalI could go on but…

Why did the authors bother with this study? Why did King’s College London publicize the study with a press release? Why was it published in Nature’s Translational Psychiatry without the editor or the reviewers catching obvious flaws?

The authors had some data lying around and selected out post-hoc a subset of patients and applied retrospective ratings and inappropriate statistics. There is no evidence of a protocol for a priority hypothesis being pursued, but strong circumstantial of p-hacking, significance chasing and selective reporting. This is not a valid study, not even an experimerciasl, it is a political, public relations effort.

soao box 2Statements in the King’s College press release echoed in the Huffington Post indicate a clear ideological agenda. Anyone who knows anything about psychiatry, neuroscience, cognitive behavior therapy for psychosis is unlikely to be persuaded. Anyone who examines the supplementary statistical tables armed with minimal statistical sophistication will be unimpressed, if not shocked. We can assume that as a group, these people would quickly leave the conversation about cognitive behavior therapy for psychosis literally rewiring the brain, if they ever got engaged.

The authors were not engaging relevant audiences in intelligent conversation. I can only presume that they were targeting naive vulnerable patients and their families having to make difficult decisions about treatment for psychosis. And the authors were preaching to the anti-psychiatry crowd. One of the authors also appears as an author of Understanding Psychosis, a strongly non-evidence-based advocacy of cognitive behavior therapy for psychosis, delivered with a hostility towards medication and psychiatrists (See my critique.) I did know that about this author until I read the materials I’ve been reviewing. It is an important bit of information and speaks to the author’s objectivity and credibility.

Obviously, the press office of King’s College London depends a lot, maybe almost entirely, on the credibility of authors associated with that institution. Maybe next time, they should seek an independent evaluation. Or maybe they are  just interested in publicity about research of any kind.

But why was this article published in the seemingly prestigious Nature journal, Translational Psychiatry? It should be noted that this journal is open access, but with exceptionally pricey Article Processing Costs (APCs) of £2,400/$3,900/€2,800. Apparently adequate screening and appropriate peer review are not including in these costs. These authors have purchased a lot of prestige. Moreover, if you want to complain about their work in a letter to the editor, you have to pay $900. So the authors have effectively insulated themselves from critics. Of course, is always blogging, PubMed Commons and PubPeer for post-publication peer review.

I previously blogged about another underpowered, misreported study claiming to have identified a biomarker blood test for depression. The authors were explicitly advertising that they were seeking commercial backers for their blood test. They published in Translational Psychiatry. Maybe that’s the place to go for placing outlandish claims into open access – where anybody can be reached – with a false assurance of a prestige protected by rigorous peer review.