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.

Troubles in the Branding of Psychotherapies as “Evidence Supported”

Is advertising a psychotherapy as “evidence supported,”  any less vacuous than “Pepsi’s the one”? A lot of us would hope so, having campaigned for rigorous scientific evaluation of psychotherapies in randomized controlled trials (RCTs), just as is routinely done with drugs and medical devices in Evidence-based Medicine (EBM). We have also insisted on valid procedures for generating, integrating, and evaluating evidence and have exposed efforts that fall short. We have been fully expecting that some therapies would emerge as strongly supported by evidence, while others would be found less so, and some even harmful.

Some of us now despair about the value of this labeling or worry that the process of identifying therapies as evidence supported has been subverted into something very different than we envisioned.  Disappointments and embarrassments in the branding of psychotherapies as evidence supported are mounting. A pair of what could be construed as embarrassments will be discussed in this blog.

Websites such as those at American Psychological Association Division 12 Clinical Psychology and SAMHSA’s National Registry of Evidence-based Programs and Practices offer labeling of specific psychotherapies as evidence supported. These websites are careful to indicate that a listing does not constitute an endorsement. For instance, the APA division 12 website declares

This website is for informational and educational purposes. It does not represent the official policy of Division 12 or the American Psychological Association, nor does it render individual professional advice or endorse any particular treatment.

Readers can be forgiven for thinking otherwise, particularly when such websites provide links to commercial sites that unabashedly promote the therapies with commercial products such as books, training videos, and workshops. There is lots of money to be made, and the appearance of an endorsement is coveted. Proponents of particular therapies are quick to send studies claiming positive findings to the committees deciding on listings with the intent of getting them acknowledged on these websites.

But now may be the time to begin some overdue reflection on how the label of evidence supported practice gets applied and whether there is something fundamentally wrong with the criteria.

Now you see it, now, you don’t: “Strong evidence” for the efficacy of acceptance and commitment therapy for psychosis

On September 3, 2012 the APA Division 12 website announced a rating of “strong evidence” for the efficacy of acceptance and commitment therapy for psychosis. I was quite skeptical. I posted links on Facebook and Twitter to a series of blog posts (1, 2, 3) in which I had previously debunked the study claiming to demonstrate that a few sessions of ACT significantly reduced rehospitalization of psychotic patients.

David Klonsky, a friend on FB who maintains the Division 12 treatment website quickly contacted me and indicated that he would reevaluate the listing after reading my blog posts and that he had already contacted the section editor to get her evaluation. Within a day, the labeling was changed to “designation under re-review as of 9/3/12”and it is now (10/16/12) “modest research support.”

David Klonsky is a serious, thoughtful guy with an unenviable job: keeping the Division 12 list of evidence supported treatments updated. This designation is no less important than it once was, but it is increasingly difficult to engage burned out committee members to evaluate the flood of new studies that proponents of particular therapies relentlessly send in. As we will see with this incident, the reports of studies that are considered are not necessarily reliable indicators of the efficacy of particular treatments, even when they come from prestigious, high impact journals.

The initial designation of ACT as having “strong evidence” for psychosis was mainly based on a single, well promoted study, claims for which made it all the way to Time magazine when it was first published.

Bach, P., & Hayes, S.C. (2002). The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: A randomized controlled trial. Journal of Consulting and Clinical Psychology, 70, 1129-1139.

Of course, the designation of strong evidence requires support of two randomized trials, but the second trial was a modest attempt at replication of this study and was explicitly labeled as a pilot study.

The Bach and Hayes  article has been cited 175 times as of 10/21/12 according to ISI Web of Science, mainly  for claims that appear in its abstract: patients receiving up to four sessions of an ACT intervention had “a rate of rehospitalization half that of TAU [treatment as usual] participants over a four-month follow-up [italics added].” This would truly be a powerful intervention, if these claims are true. And my check of the literature suggests that these claims are almost universally accepted. I’ve never seen any skepticism expressed in peer reviewed journals about the extraordinary claim of cutting rehospitalization in half.

Before reading further, you might want to examine the abstract and, even better, read the article for yourself and decide whether you are persuaded. You can even go to my first blog post on this study where I identify safe some of the things to look for in evaluating the claims. If these are your intentions, you might want to stop reading here and resume after considering these materials.

Warning! Here comes the spoiler.

  • It is not clear that rehospitalization was originally set as the primary outcome, and so there is a possible issue of a shifting primary outcome, a common tactic in repackaging a null trial as positive. Many biomedical journals require that investigators publish their protocols with a designated primary outcome before they enter the first patient into a trial. That is a strictly enforced requirement  for later publication of the results of the trial. But that is not yet usually done for RCTs testing psychotherapies.The article is based on a dissertation. I retrieved a copy andI found that  the title of it seemed to suggest that symptoms, not rehospitalization, were the primary outcome: Acceptance and Commitment Therapy in the Treatment of Symptoms of Psychosis.
  • Although 40 patients were assigned to each group, analyses only involved 35 per group. The investigators simply dropped patients from the analyses with negative outcomes that are arguably at least equivalent to rehospitalization in their seriousness: committing suicide or going to jail. Think about it, what should we make of a therapy that prevented rehospitalization but led to jailing and suicides of mental patients? This is not only a departure from intention to treat analyses, but the loss of patients is nonrandom and potentially quite relevant to the evaluation of the trial. Exclusion of these patients have substantial impact on the interpretation of results: the 5 patients missing from the ACT group represented 71% of the reported rehospitalizations  and the 5 patients missing from the TAU group represent 36% of the reported rehospitalizations in that group.
  • Rehospitalization is not a typical primary outcome for a psychotherapy study. But If we suspend judgment for a moment as to whether it was the primary outcome for this study, ignore the lack of intent to treat analyses, and accept 35 patients per group, there is still not a simple, significant difference between groups for rehospitalization. The claim of “half” is based on voodoo statistics.
  • The trial did assess the frequency of psychotic symptoms, an outcome that is closer to what one would rely to compare to this trial with the results of other interventions. Yet oddly, patients receiving the ACT intervention actually reported more, twice the frequency of symptoms compared to patients in TAU. The study also assessed how distressing hallucinations or delusions were to patients, what would be considered a patient oriented outcome, but there were no differences on this variable. One would think that these outcomes would be very important to clinical and policy decision-making and these results are not encouraging.

This study, which has been cited 64 times according to ISI Web of Science, rounded out the pair needed for a designation of strong support:

Gaudiano, B.A., & Herbert, J.D. (2006). Acute treatment of inpatients with psychotic symptoms using acceptance and commitment therapy: Pilot results. Behaviour Research and Therapy, 44, 415-437.

Appropriately framed as a pilot study, this study started with 40 patients and only delivered three sessions of ACT. The comparison condition was enhanced treatment as usual consisting of psychopharmacology, case management, and psychotherapy, as well as milieu therapy. Follow-up data were available for all but 2 patients. But this study is hardly the basis for rounding out a judgment of ACT as efficacious for psychosis.

  • There were assessments with multiple conventional psychotic symptom and functioning measures, as well as ACT specific measures. The only conventional measure to achieve significance was distress related to hallucinations and there were no differences in ACT specific measures. There were no significant differences in rehospitalization.
  • The abstract puts a positive spin on these findings: “At discharge from the hospital, results suggest that short-term advantages in effect of symptoms, overall improvement, social impairment, and distress associated with hallucinations. In addition, more participants in the ACT condition reach clinically significant symptom improvement at discharge. Although four-month rehospitalization rates were lower in the ACT group, these differences did not reach statistical significance.”

The provisional designation of ACT as having strong evidence of efficacy for psychosis could have had important consequences. Clinicians and policymakers could decide that merely providing three sessions of ACT is a sufficient and empirically validated approach to keep chronic mental patients from returning to the hospital and maybe even make discharge decisions based on whether patients had received ACT. But the evidence just isn’t there that ACT prevents rehospitalization, and when the claim is evaluated against what is known about the efficacy of psychotherapy for psychotics, it appears to be an unreasonable claim bordering on the absurd.

The redesignation of ACT as having modest support was based on additional consideration of a follow-up study of the Bach and Hayes, plus an additional feasibility study that involved 27 patients randomized to either to treatment as usual or 10 sessions of ACT plus treatment as usual. Its stated goal was to investigate the feasibility of using ACT to facilitate emotional recovery following psychosis, but as a feasibility study, included a full range of outcomes with the intention of deciding which would be important for assessing the impact of ACT in this population. The scales included the two subscales of the Hospital Anxiety and Depression Scale (HADS), the positive and negative syndrome scale, an ACT specific scale, and a measure of the therapeutic alliance.  Three of the patients assigned just treatment as usual dropped out and so intent to treat analysis were not conducted. With such a small sample, it is not surprising that there were no differences on most measures. The investigators noted that the patients receiving ACT and had fewer crisis contacts over the duration of the trial, but it is not clear whether this is simply due to the treatment as usual group not having regular treatment and therefore having to resort to crisis contacts.

The abstract of the study states “ACT appears to offer promise in reducing negative symptoms, depression and crisis contacts in psychosis”, which is probably a bit premature. Note also that across these three trials, there is a shift in the outcome to which the investigators point as evidence for the efficacy of ACT for psychosis. The assumption seems to be that any positive result can be claimed to represent a replication, even if other variables were cited for this purpose among the other studies.

Overall, this trial would also be rated as having high risk of bias because of the lack of intent to treat analyses and the failure to specify a primary outcome among the battery that was administered, but more importantly, it would simply be excluded from meta-analyses with which I have been associated because of too few patients in it. A high risk of bias plus too few patients discourages any confidence in these results.

Is treating PTSD with acupoint stimulation supported by evidence ?

Whether or not ACT is more efficacious than other therapies, as its proponents sometimes claim, or whether it is efficacious for psychosis, is debatable, but probably no one would consider ACT anything other than a bona fide therapy. The same does not hold for Emotional Freedom Therapy (EFT) and its key component, acupoint.  I’m sure there was much consternation at APA and Division 12 when stories circulated on the Internet that APA had declared EFT to be evidence supported.

Wikipedia offers the following definition of EFT:

Emotional Freedom Techniques (EFT) is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy. During an EFT session, the client will focus on a specific issue while tapping on so-called “end points of the body’s energy meridians.”

Writing in The Skeptical Inquirer, Brandon Gaudiano and James Herbert argued that there is no plausible mechanism to explain how the specifics of EFT could add to its effectiveness and they have been described as unfalsifiable and therefore pseudoscientific. EFT is widely dismissed by skeptics, along with its predecessor, Thought Field Therapy and has been described in the mainstream press as “probably nonsense.”[2] Evidence has not been found for the existence of acupuncture points, meridians or other concepts involved in traditional Chinese medicine.

The scathing Gaudiano and Herbert critique is worth a read and calls attention to claims of EFT by proxy: patients improve when therapists tap themselves rather than the patients! My imagination runs wild: how about televised sessions in which therapists tap themselves and liberate thousands of patients around the world from their PTSD?

According to David Feinstein, aproponent of EFT, in including a chapter on Thought Field Therapy in an anthology of innovative psychotherapies, Corsini (2001) acknowledged that it was “either one of the greatest advances in psychotherapy or it is a hoax.”

Claims have been made for acupoint that even proponents of EFT consider “provocative,” “extraordinary,”  and “too good to be true.” An article published in Journal of Clinical Psychology (not an APA journal), reported that 105 people were treated in Kosovo for severe emotional reactions to past torture, rape, and witnessing loved ones being burned or raped. Strong improvement was observed in 103 of these patients, despite an average of only three sessions. For comparison purposes, exposure therapy involves at least 15 sessions in the literature claims nowhere near this efficacy. However, even more extraordinary results were claimed for the combined sample of 337 patients treated in visits to Kosovo, Rwanda, the Congo, and South Africa. The 337 individuals expressed 1016 traumatic memories of which 1013 were successfully resolved, resulting in substantial improvement in 334 patients. Unfortunately the details of this study remain on unpublished, but claims of these results appear in a forthcoming article in the APA journal Review of General Psychology.

Reports circulating on the Internet that APA had declared EFT to be an evidence supported approach stemmed from a press release by the EFT Universe that cited a statement from the same Review of General Psychology article:

A literature search identified 50 peer-reviewed papers that report or investigate clinical outcomes following the tapping of acupuncture points to address psychological issues. The 17 randomized controlled trials in this sample were critically evaluated for design quality, leading to the conclusion that they consistently demonstrated strong effect sizes and other positive statistical results that far exceed chance after relatively few treatment sessions. Criteria for evidence-based treatments proposed by Division 12 of the American Psychological Association were also applied and found to be met for a number of conditions, including PTSD (Feinstein, 2012).

Feinstein had been developing his claims about energy therapies such as EFT meeting the Division 12 criteria for a while. In a 2008 article in the APA journal Psychotherapy Theory, Research, Practice, Training, he declared

although the evidence is still preliminary, energy psychology has reached the minimum threshold for being designated has an evidence-based treatment, with one form having met the APA division 12 criteria as a “probably efficacious” treatment for specific phobias; another for maintaining weight loss.

In this 2008 article, Feinstein also cited a review in the online book review journal of APA in which Ilene Selrin, Past President of APA’s Division of Humanistic Psychology praised Feinstein’s book for its “valuable expansion of the traditional biopsychosocial model of psychology to include the dimension of energy” and energy psychology as representing “a new discipline that has been receiving attention due to its speed and effectiveness with difficult cases.”

The reports that EFT had been designated as an evidence supported treatment made the rounds for a few months, sometimes with the clarification that EFT met the criteria, but had not yet been labeled as evidence supported by Division 12. In some communities, stories about EFT or –as it was called– tapping therapy made the local TV news. KABC news Los Angeles titled a story,”‘Tapping’ therapy can relieve anxiety, stress, researchers say” and got an APA spokesperson to provide a muted comment

 “Has this tapping therapy been proven effective? We don’t think so at this point,” said Rhea Farberman, Executive Director for Public and Member Communications at the APA.

The comment went on to say that APA viewed stress and anxiety as serious but treatable issues for some persons and cognitive behavior therapy recommended, but not tapping therapy.

What do these incidents say about branding of psychotherapies as evidence supported?

I will explore this issue in greater depth in a future blog post, but for now we are left with some questions.

The first incident involved designation of a psychotherapy as having strong evidence of efficacy for psychosis, but was quickly changed first to under review and then to modest support. The precipitant for this downgrading seems to be blog posts that revealed the abstract of the key study to be misleading. Designation of a therapy as having strong evidence for its efficacy requires two positive randomized controlled trials. The second trial was described as a pilot study explicitly aimed at replicating the first one. Like the first one, its abstract declared positive findings. However, this study failed to replicate the first study’s claimed reduction in hospitalization, and a cursory examination of the results section revealed that this study, like the study that it attempted to replicate, was basically a null trial.

  • Do the current criteria employed by Division 12-only 2 positive trials and no attention to size or quality- set too low a bar for a therapy receiving the seemingly important branding of having strong evidence?
  • The revised status of ACT for psychosis is that it has modest support. But how does two null trials published with confirmatory bias constitute modest support?
  • Are there pitfalls in uncritically accepting claims in the abstracts of articles appearing in prestigious journals like JCCP?
  • More generally, to what extent do the shortcomings of articles appearing in prestigious journals like JCCP warrant skepticism, not only by reviewers for Division 12, but consumers more generally?
  • Should we expect a prestigious journals like JCCP to encourage and make a place for post publication peer review of the articles that have appeared there?
  • Should revised criteria for evidence supported therapies not just count whether there are two or only one positive trial, but incorporate formal quality ratings of trials for overall quality and risk of bias?

The second incident involves rumors of APA having designated as evidence supported a bizarre therapy with extravagant claims of efficacy. The rumor was based on a forthcoming review in an APA Journal that indicated that EFT had sufficient number of positive randomized trials to meet APA division 12 criteria for evidence supported. It was left to a media person from APA to clarify that APA did not endorse this therapy, but it was unclear on what basis this declaration was made.

  • If ACT for psychosis has modest support, where does EFT stand when evaluated by the same criteria?
  • Can sources other than APA Division 12 apply the criteria to psychotherapies and declare the therapies as warranting evidence-based status? If not, why not?
  • Do consumers, as well as proponents of innovative and even strange therapies, deserve evaluation with formal criteria by APA Division 12 and designation of the therapies not only as warranting a designation of “strong evidence” if they meet these criteria, but alternatively as having demonstrated a failure to accumulate evidence of efficacy, and even as having demonstrated possible harm?
  • If APA Division 12 takes on the task of publicizing the evidence based status of psychotherapies, does it thereby assume a responsibility to alert policy makers and consumers of therapies that fail to meet these criteria?
  • If application of the existing Division 12 criteria warrants EFT as having strong evidence of efficacy, what does that say about the adequacy of these criteria?

To be continued……