Psilocybin as a treatment for cancer patients who are not depressed: the NYU study

psilocybinThe well orchestrated promotion of a modest and misrepresented pair of studies of using psilocybin with cancer patients raises lots of issues and should leave lots of people embarrassed.

A breakdown in peer review allowed unmoderated and misleading statements about the studies to appear in commentaries from an impressive array of leading psychiatrists. They embarrassed themselves by claiming the studies were well-designed trials and that the patients were clinically depressed.

There was a breakdown in the press’s evaluation of press releases from the studies, with journalists embarrassing themselves by passing on outrageously self-congratulatory statements by the authors without independently checking them. Journalists covering the story almost exclusively drew on a rich set of promotional materials from the authors’ institutions and added little else.

A lot of commentators in the social media, especially Twitter, embarrassed themselves by tweeting and liking others’ tweets with unbridled, uncritical enthusiasm for the claims of the authors. They obviously did not read the papers or read them carefully.

From the 1960s, the United States has had an irrational policy of criminalizing use of psilocybin. The articles and publicity campaign do not directly challenge this policy or call for decriminalization. Rather, they propose establishing a loophole by which people of means can obtain a diagnosis of adjustment disorder from a psychiatrist, receive a prescription for psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine), and purchase an elaborate ceremony with lots of pseudoscientific trappings and mystical explanations. Use by others outside of this context will remain criminalized.

The publicity campaign can be seen as a larger effort by psychiatry to define dying as a mental health issue, routinely requiring their specialty expertise and services.

The articles’ justification for the trials runs roughshod over the existing literature, exaggerating psychiatric aspects of cancer, and minimizing the needs and preferences of cancer patients.

Hopefully, by the end of this blog and the next, I will convince readers that my assessments are more reasonable than they first appear.

Although published in a pay wall journal, both articles were made freely available, along with some of the laudatory comments, mostly from psychiatrists.

The first article is

Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Journal of Psychopharmacology. 2016 Dec 1;30(12):1165-80.

The trial’s freely available registration at ClinicalTrial.gov is available here.

In this first of two blog posts, I will center on this study. However, a forthcoming blog post will focus on the second article, comparing and contrasting it to another study in methods and interpretation :

Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology. 2016 Dec 1;30(12):1181-97.

The trial’s available registration is at ClinicalTrial.gov is available here. https://clinicaltrials.gov/ct2/show/NCT00465595

Distortions in coverage of the literature in the introduction to Ross et al study at NYU

 The introduction states:

Enduring clinically significant anxiety and/or depressive symptoms are common in patients with cancer, present in 30–40% of patients in hospital settings (Mitchell et al., 2011).

I debated Alex Mitchell, the author of this review to a packed audience at the International Association for Psycho-oncology meeting in Rotterdam.  Here are my slides.

I pointed out that these estimates are of self-reported symptoms, not clinical diagnoses, which is substantially lower. Although there is a modest elevation in self-reported symptoms immediately after diagnosis, there is a trajectory of rapid decline. Only about 12% of patients have heightened distress at six months, and is likely that many of those that do, had pre-existing psychological disorders or past histories. After the initial stress of a diagnosis, rates of distress among patients in an oncology waiting room approximate the rates of patients in primary care waiting rooms.

These symptoms are associated with a variety of poor outcomes, including medication non-adherence, increased health care utilization, adverse medical outcomes, decreased quality of life, decreased social function, increased disability, hopelessness, increased pain, increased desire for hastened death, increased rates of suicide, and decreased survival rates (Arrieta et al., 2013; Brown et al., 2003; Jaiswal et al., 2014).

These correlations are not established as causal, and mostly come from cross-sectional studies. Residual confounding and reverse causality are highly likely. Patients with more debilitating physical symptoms inadequately controlled pain register more distress. There is no evidence that treating depression increases survival rates or slows progression.

The introduction goes on to mention that effects of antidepressants have a slow onset and they are incompletely effective. The author should have noted that antidepressant treatment would be inappropriate for the patients with adjustment disorders that dominated their study sample.

…With a growing body of evidence linking higher levels of existential/spiritual wellbeing (in cancer patients) with improved quality of life and decreased depression/hopelessness/suicidality (Breitbart et al., 2000; McClain et al., 2003; Nelson et al., 2002), the need to develop effective therapeutic approaches to mitigate this domain of distress has become increasingly recognized within the disciplines of palliative care and psycho-oncology.

Hold on! The authors are introducing some pretty shabby research that psychiatrists should be addressing existential/spiritual well-being.Since when are existential/spiritual well-being issues psychiatric?

A number of manualized “existentially oriented psychotherapies” for cancer patients have been developed to address these existential/spiritual issues, with some empirical support from clinical trials (Lemay and Wilson, 2008), and several of these approaches were integrated into the therapy platform developed for this study.

I will pick up on this discussion in my next blog post. But in a previous blog post, I examined the largest trial (with 441 palliative care patients) for one of these “existential/spiritual” therapies.

That study found no differences in 22 different measures of distress (!) between a mental health professional delivering an existential/spiritual “dignity therapy” over standard palliative care or a client centered care delivered by a nurse. Nonetheless, in New York, you can find expensive continued education courses offered by psychiatrist for this dignity therapy.Having been evaluated in a large clinical trial does not necessarily make a treatment “evidence-based,” particularly when it only achieved no findings.

One of the problems acknowledged in that trial is that only a small proportion of palliative care patients had clinically significant anxiety and depression scales. This study is a particularly interesting comparison compared to the study of psilocybin for cancer patients. Palliative care patients in the larger study are arguably more confronting of an impending death than the patients in the psilocybin study. Yet the authors of the psilocybin study make a broad assumption that end-of-life is a time of considerable distress and a mental health issue.

Methods and results of the Ross et al study at NYU

Patients in the NYU Psilocybin Cancer Anxiety Study begin their hallucinatory experience wearing eyeshades and headphones as doctors encourage them to bear witness to an inner world - Photo and description provided by NYU Alumni News
Patients in the NYU Psilocybin Cancer Anxiety Study begin their hallucinatory experience wearing eyeshades and headphones as doctors encourage them to bear witness to an inner world – Photo and description provided by NYU Alumni News

Representing only about a third of the patients screened for the study, 29 patients were randomized to either psilocybin or niacin (vitamin B3) in a cross over design. The randomized patients were highly educated and almost half had a history of use of hallucinogens. Almost all patients (93%) indicated “white” as their race. No patients endorsed black, Hispanic, Asian, or Native American. All but five patients had diagnoses of adjustment disorder, and these other five had diagnoses of general anxiety disorder. Although about two thirds of the patients had stage III or stage IV cancer, the rest had stage I or stage II. is not clear why they allow such heterogeneity of patients expected survival time in their study. I suspect they had trouble recruiting patients.

Regardless, my immediate observation is that this is a highly unrepresentative sample. For psychiatry journal, it would usually be considered a misrepresentation to use “anxiety “ and “depression” in a title when we’re sample did predominantly not have diagnoses of major depression in clinical anxiety disorders. When did you last see “life-threatening” in the title of a paper in an oncology or even psycho-oncology journal? With the title, we already are seeing a bit of dramatization in the service of attracting more attention than a more accurate and conventional title.

Any sense of a double blinded study is undone by the use of niacin as a comparison/control. Patients would shortly discover whether they had been given vitamin B3 or a hallucinogenic drug in any research assistants would notice the difference.

The abstract mentions that the psilocybin and the vitamin B3 were administered after a preparatory psychotherapy session. The therapy was then delivered at during both the psilocybin and vitamin B3 treatments. Thus, that this is not simply treatment with psilocybin, but with a psilocybin/psychotherapy combination. There is not even minimal description of this psychological treatment in the article.

However,  if you go to the NYU Alumni Magazine, you’ll find an extensive interview and photos of some of the investigators. You’ll learn that both psilocybin and vitamin B3 are administered with a special ceramic chalice. Description of the psychotherapy is certainly what you would not expect for a manualized therapy. But the following section of the article is enlightening:

The NYU Psilocybin Cancer Anxiety Study is conducted in a serene space that seems more like someone’s living room than part of a bustling research clinic. There’s a couch strewn with ethnic-printed pillows, shelves stocked with oversize books of Tibetan art, framed landscape photographs, warm pools of lamplight, Buddha figurines, and, on dosing days, fresh fruit and flowers.

Notwithstanding the lovely room, psilocybin does present risks. Although it is not known to induce addiction, overdose, or withdrawal symptoms, some research has suggested it can bring about prolonged psychosis in people with a personal or family history of major mental illness, so such patients are carefully screened out of the study. In the session itself, there may be some physical side effects, such as nausea, dizziness, and tremors, but the more pronounced hazards are psychological. Periods of transient anxiety can occur as patients navigate the challenging psychological material related to cancer. More extreme reactions, such as paranoia and panic, can occur, but are rare and safeguarded against through careful preparation and a highly structured therapy session, much of which is influenced by the rituals of indigenous cultures that utilize psychedelic medicines.

Subjects start with a series of meetings with a male-female therapist dyad to build trust, establish familiarity, and set intentions. On the dosing day—there is one for placebo and one for the real thing, set seven weeks apart—a small container of psilocybin synthesized in a government-monitored laboratory and weighed daily according to strict DEA regulations is taken from an 800-pound safe. Twenty milligrams of powder, an amount precisely judged to increase the likelihood of a mystical experience, are measured and pressed into a pill, which subjects swallow from a ceramic chalice.

The drug starts to take hold after about half an hour and the subjects are encouraged to put on eyeshades and headphones, lie down, and ride the waves of music on a carefully curated playlist. The therapists sit quietly nearby. There’s often sobbing and sometimes laughter. After a few hours, subjects usually remove their eyeshades and start bearing witness to the inner world they’ve traversed.

This investigator’s New Age depiction of mechanism falls short of conventional scientific standards”

“People come out with an acceptance of the cycles of life,” Bossis says. “We’re born, we live, we find meaning, we love, we die, and it’s all part of something perfect and fine. The emergent themes are love, and transcending the body and this existence. In oncology, we’re pretty good at advancing life and targeting chemotherapies, but we’re not so good at addressing deep emotional distress about mortality. So to see someone cultivate a sense of acceptance and meaning, something that we all hope to cultivate over a 90-year life, in six hours? It’s profound.”

This study evaluated as a clinical trial

This study is grossly underpowered study, involving an unrepresentative sample of 29 patients whose only diagnosis was an adjustment disorder, with the exception of a few patients with generalized anxiety. Diagnoses of adjustment disorders are not validated nor have they received extensive study. If a patient has some distress with recent onset and they want to see a mental health professional, they can be given a diagnosis of adjustment disorder to justify treatment. For a while, that was a common practice in the Netherlands, but treatments billed for adjustment reactions are no longer allowed.

I’m sure where I got this phrase, but I sometimes refer to adjustment disorder as an acute compensatory reaction of psychiatrists seeking to bill for services.

The idea that this is a blinded trial is ridiculous. Very soon after administration of the drug,  patients and clinical and research staff knew whether the patients had received psilocybin or vitamin B3.

chalice used in studyA chalice was used to administer both psilocybin and vitamin B3. Once patients became unblinded by noticing any effects of the drug they had been given, the chalice added to the sense of this supposed to be a mystical experience. There is more than a little hokum in play.

We’re told little about the psychotherapy, but enough to reveal that it has strong nonspecific factors and should induce strong positive expectations.

Crossover designs provide weak evidence, particularly ones that are readily unblinded and if we are interested in any effects of the first treatment after the crossover. Patients immediately realized in the first session whether they were assigned to psilocybin or vitamin B3. Awareness of their first treatment assignment further unblinded them to the next phase of the trial. Patients who received psilocybin in the first session (and clinical and research staff assigned to them) knew that they were going to get. Because psilocybin was expected to have lasting effects, it would be predicted that patients assigned to the vitamin B3 in the second session would nonetheless exhibit the lowered self-reported symptoms, due to the effects of earlier psilocybin. So what was the point?

The crossover design means that any expected natural decline in distress will be folded into effect of treatment. That is, it’s well-known that the distress of cancer patients has a strong natural declining trajectory. That natural decline in distress will be interpreted as part of the effects of the treatment.

For each of the six primary outcome measures (HADS T, HADS A, HADS D, BDI, STAI S, STAI T), there were significant differences between the experimental and control groups (prior to the crossover at 7 weeks post-dose 1) with the psilocybin group (compared to the active control) demonstrating immediate, substantial, and sustained (up to 7 weeks post-dosing) clinical benefits in terms of reduction of anxiety and depression symptoms. The magnitude of differences between the psilocybin and control groups (Cohen’s d effect sizes) was large across the primary outcome measures, assessed at 1 day/2 weeks/6 weeks/7 weeks post-dose 1.

And:

Compared to the control, psilocybin produced mystical-type experiences, consistent with prior trials of psilocybin administration in normal volunteers (Griffiths et al., 2006, 2008, 2011).

Conflict of interest

 The authors declared no conflict of interest. However they indicate that a private foundation advocating use of psilocybin funded the study and professionals associated with this foundation provided preliminary review of the manuscript before it was published.

The foundation’s involvement in the funding study in vetting of the manuscript does not necessarily invalidate results reported in the manuscript, but readers have the right to be informed of this potential conflict of interest.

Coming up next: the Johns Hopkins study and integrated discussion

 Undoubtedly, ingesting psilocybin in a setting in which expectations are well structured can be a positive experience. I can say that from experience. Yet it is criminalized in the United States to sell, purchase, or ingest psilocybin. The study seems clearly aimed at creating a loophole for cancer patients who engaged psychiatrists. What’s wrong with that? What’s wrong with anybody being able to obtain psilocybin of assured purity and consume it in a pleasant safe environment with a knowledgeable guide whom they trust?

Suppose the cancer patient was a skeptic like myself and did not want to submit to the mumble jumble psychotherapy offered in this trial. Particularly if they were experienced taking psychedelics, as almost half of the patients were in the study, shouldn’t they be able to go to a primary care physician and get a prescription for psilocybin of known doses and purity, and go home and take it with a trusted friend or two? What if someone did not have cancer, but like many patients in primary care waiting rooms, had distress elevated to the degree that participants in the study did. Should they be allowed to self-administer psilocybin?

It’s a wise idea to take psilocybin with a knowledgeable friend in a context conducive to a good experience. Why should somebody have to involve a psychiatrist? People experience was psilocybin are aware in someone else’s experience is becoming anxiety provoking, and can usually appropriately distract them away and into a more pleasant experience.

It’s a wise idea not to go scuba diving alone, but to be accompanied by a knowledgeable friend. Should scuba divers also be required to take their psychiatrists along?

Okay, you as a reader may personally have no interest in taking psilocybin out of the presence of a psychiatrist anymore than having any interest in scuba diving, with or without a psychiatrist. You may even object to people doing so and considerate it foolish. But should the people, whether suffering from cancer or not, taking psilocybin at home with friends be subject to steep fines and jail time

We will next discuss the other study of psilocybin administered to cancer patients. We will also examine the larger issues of the commentaries that accompanied this set of articles and the press coverage that they were given.

In the meantime and afterwards, I certainly welcome back talk in comments on this blog.

 

 

 

 

 

 

 

 

Is dying a mental health issue?

Should a dying patient talking to a psychiatrist be diagnosed with adjustment disorder related to death?

 Dare we ask: Could impending death not be sufficiently psychologically distressing for patients to routinely benefit from psychotherapy?

2Presentation1Patients aware that they are dying often wish to talk to someone about their predicament. Should psychiatrists and psychologists be the first line professionals for such discussions? After all, aren’t many dying patients experiencing substantial psychological distress? Specialty mental health professionals would have the skills to differentially diagnose this distress and offer appropriate targeted treatment. And what about their ability to identify and address issues of suicidality?

Or should discussions be left to clergy and pastoral counselors, especially for patients of faith?

Raising these questions could easily get us into philosophical and spiritual issues where we might feel excused from having to bring in evidence. But a relatively large-scale and well-designed study has given us a relevant answer. Maybe not the answer that the investigators hoped to find and they probably will not like my further interpretation. And, sure, it is only one randomized trial, but results seem to speak exceptionally clearly about a number of issues.

The study was negative, but demonstrates just how much a well-designed negative trial can reveal.

The study appeared in the prestigious Lancet Oncology (Journal impact factor [JIF] = 21.12), along with a commentary.

Chochinov, H. M., Kristjanson, L. J., Breitbart, W., McClement, S., Hack, T. F., Hassard, T., & Harlos, M. (2011). Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. The Lancet Oncology, 12(8), 753-762.

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The randomized trial was conducted with a large sample (441) of patients recruited from hospices and home-based palliative care in Australia, Canada, and the United States. Investigators compared their preferred intervention, dignity therapy (165 patients), to two comparison/ conditions – standard palliative care (140 patients) and client-centered care (136 patients).

 

Stated goal

This study represents the first randomized control trial of Dignity Therapy. We set out to determine if this novel psychotherapeutic approach would significantly outperform standard care, or Client Centered Care…on various measures of psychological, existential and spiritual distress.

Primary outcome. The primary outcome was distress, which sounds simple enough, but it was measured 23 different ways. No one variable was designated as the primary outcome for the purposes of evaluating the effectiveness or ineffectiveness of dignity therapy would be judged. There are also 22 different secondary outcomes, single items evaluating patients’ experience participating in the intervention.

The three conditions

Dignity Therapy provides patients with life-limiting illnesses an opportunity to speak about things that matter most to them. The conversations are recorded and transcribed to provide the basis for a document that patients can bequeath to individuals of their choosing.

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Patients were shown the Dignity Therapy question framework Table 1] and asked to consider what they might wish to speak about during their Dignity Therapy session(s); this initial introduction to, and explanation of Dignity Therapy took about 30 minutes. Within a few days, or as soon as a second meeting could be arranged, the therapist used the question framework to help elicit the patient’s recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind. Dignity Therapy is flexible enough to accommodate participant preferences and choices regarding content, but the ethos of questioning targets those things that might enhance a sense of meaning, purpose, continued sense of self, and overall sense of dignity. All Dignity Therapy sessions were audio-taped; these sessions usually took about 60 minutes. Upon completion, the audio-recording was transcribed verbatim and the transcript edited, to provide a clear and readable narrative. This transcript or `generativity document’ was returned to the patient..,[and] read to them in its entirety to ensure that no errors of omission or commission needed to be addressed (this final session usually took about 30 minutes). .. The final version of the generativity document was then given to the patient, to be passed along to a designated recipient of their choosing.

dignity therapy tell themTherapists for the dignity therapy were psychologists, psychiatrists, or experienced palliative care nurses.

Generativity is a key concept in dignity therapy.

Generativity or the ability to guide the next generation, encompasses how patients might find strength or comfort in knowing that they will leave behind something lasing and transcendent after death.

Some readers may recognize the similarity of the investigators’ concept of generativity and Erik Erikson’s life stage of generativity versus stagnation.

In Standard Palliative Care patients had access to a full range of palliative care support services, including specialist palliative care physicians and nurses with expertise pain and symptom management, social workers, clergy, and mental health professionals.

There were not, however, any components of standard palliative care directly comparable to the dignity therapy.

Client Centred Care was a supportive psychotherapeutic approach, in which the therapist guides patients through discussions focusing on here and now issues. These might include their illness and symptoms and what is being done to address symptom distress. However, in order to keep this condition distinct from dignity therapy, the therapist did not encourage discussion of issues of meaning and purpose. If these topics came up, the therapist redirected the conversation back to illness-related issues.

The therapist for client-centred care was a research nurse.

What was found.

nothingNo evidence was found that that dignity therapy reduced distress across 22 different measures of distress, including overall scores and subscale scores from an array of measures.

The 23 items representing secondary outcomes had only a few differences between the three groups, no more than would be expected by chance. We should be careful about the statistically significant results that were obtained, but perhaps patients were expressing appreciation that they had been randomized to the specialized treatment, as well as having the document to leave for family members. With only five items dignity therapy was found to be superior to both standard palliative care and client-centred care.

The investigators’ interpretation.

Despite the beneficial effects of Dignity Therapy, its ability to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven. However, there is currently ample evidence supporting its clinical application for patients nearing death, as a means of enhancing their end-of-life experience.

While floor effects precluded our ability to demonstrate significant differences across study arms, our secondary outcomes revealed substantive benefits of Dignity Therapy. Using a post-study survey, patients who received Dignity Therapy were significantly more likely to report benefits, in terms of finding it helpful, improving their quality of life, their sense of dignity; changing how their family might see or appreciate them, and deeming it helpful to their family, compared to the other study arms.

The investigators were obviously passionate about their intervention and looked exhaustively for evidence of the efficacy of dignity therapy. They really did not find any.

What I liked about this trial.

I like the unusually large sample size and the inclusion of two different control/comparison groups the allowed answering different kinds of questions. This is certainly not an underpowered pilot study being passed off as a full randomized trial. The Standard Palliative Care group allowed determination of whether dignity therapy offered anything beyond routine care. And a reader definitely gets the sense that routine care in this study was neither no care or inadequate care, as it is with so many studies. The Client Centered Care condition pitted the investigators’ preferred intervention against a lower intensity intervention that provides support, but without an element that the investigators considered key to their intervention.

The intervention followed a structured standardized protocol. Standardized training was provided, along with group supervision and review of transcripts of recordings of actual sessions to ensure fidelity of delivery.

The study recruited from a variety of settings and had an excellent uptake from patients who were offered an opportunity to participate.

Patients were randomized with the investigators blinded as to group assignment.

What I like less

The investigators administered a full battery of potential outcome measures including total and subscale scores of

The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale, Patient Dignity Inventory, Hospital Anxiety and Depression Scale, items from the Structured Interview for Symptoms and Concerns, Quality of Life Scale, and modified Edmonton Symptom Assessment Scale.

These measures tend to be moderately to highly correlated and so having this battery available for assessment of outcome represents considerable redundancy. The investigators not designating one or two measures as the primary outcomes set the stage for the investigators selecting a primary outcome after they knew the results, risking confirmatory bias and capitalization on chance.

The investigators had to contend with substantial lots of patients, not unexpectedly, because these are palliative care patients, but they did not avail themselves of a number of ways to provide estimates for the missing data and so analyses were not intention-to-treat.

This little reason to believe that this changed the results, however, because of the floor effect that they noted.

I did not like the positive spin put on the null findings of this trial. Confirmatory bias was clear in the abstract and extended to the discussion. The structured abstract conceded a lack of effect on distress, but cherry picked positive findings to emphasize out of an overall null set of secondary outcomes. In the interpretation section of the structured abstract offered:

Although the ability of dignity therapy to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven, its benefits in terms of self-reported end-of-life experiences support its clinical application for patients nearing death.

The laudatory accompanying commentary.

The commentary on this article is an embarrassingly obvious attempt to spin and refute results the commentator did not want to accept.

Commentaries in peer-reviewed journals are typically not rigorously peer-reviewed. They tend to be written with an agenda, by reviewers who nominated themselves to write them. I have previously blogged about an unusual commentary in which the writer sought to destroy the credibility of an article she did not like, despite it having been accepted for publication. Most often, however, commentaries are laudatory and written with an awareness that the authors of the commentaries can get away with praise that would not survive peer-reviewed.

The commentator sought damage control in the face of an utter lack of significant findings. She tried to undermine the validity of an RCT for studying psychosocial interventions. It is true that clinical trials restrict participation to patients with sufficient cognitive intactness, but so do any talk therapies. Her criticism that the sample was not heterogeneous and representative was contradicted by demonstration most patients who were approached participated. Differences in baseline variables are a threat to the validity of results of an RCT, but one of the strengths of such a design is that it serves to minimize such differences. And the commentator gave no evidence that baseline differences between groups undermined the validity of this particular trial.

The commentator raised issues about the standardization of the treatment across settings, but ignored the efforts made to ensure fidelity of delivery. The commentator further ignored the efforts of the investigators to control for nonspecific factors by inclusion of both a standard care and a client centred/comparison control condition. Maybe the richness of standard care precludes finding any effect for the addition of dignity therapy, but that is a valuable finding. It sng that a specialized dignity therapy is not needed. Finally, the commentator’s suggestion that outcomes may not adequately measured is bewildering in the face of the investigators administering a battery of 22 measures for primary outcome and 23 measures for secondary outcome. What does she think is missing?

Given the effort to positively spin solidly null findings in both the article and the commentary, one has to ask under what conditions the investigators and commentator with and willing to concede that this is not a promising line of treatment development?

Why I consider this study important.

Although one does not make a definitive judgment on the basis of a single trial, there is little here to encourage further consideration of dignity therapy as an evidence-based therapy.

The investigators made the testable assumption that end-of-life is a time of considerable psychological distress. They designed an intervention to be delivered by mental health professionals to relieve that distress. They evaluated their intervention in an adequately powered randomized trial, but failed to find any evidence of an effect. The most likely reason is that this large representative sample of palliative care patients was simply not distressed enough to benefit from a mental health intervention.

One could argue that the intervention was not sufficiently intense or mental health oriented, but low baseline distress would preclude a more intense intervention succeeding. There is a floor effect going on, as the investigators recognize.

Basic pilot work would have revealed the surprisingly low levels of distress in this population. A specialty mental health oriented intervention may not be warranted with patients who are not specifically selected for distress. And furthermore, the minority of palliative care patients who show clinically significant distress may not benefit from an intervention like this. They probably would require something more intensive and specifically aimed at reducing distress, with evidence of the intervention having worked in other populations.

But the assumption that cancer patients suffer substantial psychological distress, and patients in palliative care particularly so, is so well entrenched that it is difficult to challenge. Certainly, if investigators applied for a NIH grant and stated that end-of-life is not a time of great psychological distress, they would have risked a low priority for funding.

Giving dying patients a chance to talk: Going from a feature of routine care to a treatment

The investigators failed to find that their structured intervention, dignity therapy offered benefits beyond routine care or a client centred care that had key elements removed: therapists for this condition were not allowed to discuss meaning or purpose.

Suppose investigators had found a therapy mainly provided by psychiatrists and psychologists yielded substantial reductions in distress. These findings would have reinforced existing views of palliative care patients as having high levels of distress. They would further have demonstrated the inadequacy of both good quality routine care and a client centred care modeled after what pastoral counselors offer in providing dying patients with opportunities to discuss their “recollections, hopes, wishes for loved ones; lessons learned and things they wanted remembered by those they were about to leave behind.”

Dignity therapy would be on its way to being an evidence-based treatment with demonstrated ability to reduce significant psychological distress.

And this would propel our moving what had been a feature of routine care to a formal treatment that is of necessity a billable procedure that ultimately requires a diagnosis psychiatrist and psychologist do not provide treatment without diagnosis of disorder. But with what diagnosis?

Presentation1
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The low levels of psychological distress do not indicate the likelihood of substantial psychiatric disorder in this population. There is already a suitable diagnostic category that is loose and limited in its validity, but that serves administrative purposes, adjustment disorder. Mental health professionals seeking to document the diagnosis of patients being treated with dignity therapy, but lacking any other formal psychiatric disorder, could always bill for adjustment reaction related to death. That mental health professionals wanted to treat the patient and the patient wanted treatment would in itself be an indication of distress and clinically significant impairment. And the cause of the disorder the dignity therapy targeted is impending death.

Making a diagnosis of adjustment disorder often is a successful resolution of acute compensation crisis of mental health professionals. They are not offered treatment in the absence of the diagnosis, they are treating adjustment disorder.

Psychiatrists and psychologists offer treatment in “sessions” that are of necessity of limited duration typically half hour to 50 minutes. They do so with a certain time pressure. They follow  schedules allowing only small time intervals between patients and no running over, even if the discussion is intense and productive.

In contrast, pastoral counselors do not require diagnoses for what they provide to patients. While there may be heavy demands on their time, they do not typically operate with rigidly timed “sessions” and will stay with the patient as long as needed, within practical limits. This particular trial of dignity therapy fails to find any evidence that what they do is less efficacious than a psychologist or psychiatrist.

Much of the content of dignity therapy will differ according to the religious faith of patients. It would seem that pastoral counselors could address these issues with greater authority and knowledge.

As an agnostic, I approached working with pastoral counselors in cancer care with skepticism as to whether they would take advantage of patients’ dying days to win them back to their faith. I never saw any of that happen. Rather, all the pastoral counselors I have ever seen have a deep respect for patients’ level of commitment to their faith – or lack thereof. I would characterize what they do is provide a presence for patients’ talking about things that matter to them, nondirectively guiding the conversation forward, but without imposition of their own views.

How do we evaluate what pastoral counselors do? If what they provide is not considered treatment, there is no issue of whether it is evidence-based treatment. It does not require that patients be distressed in order to be eligible for a discussion, nor that the distress be resolved for the discussion to be “successful.”

An example from primary care illustrates some of the “crisis” of medical care in the United States and in many countries that extends to cancer care, dignity therapy would be implemented.

Click to enlarge http://minnesota.cbslocal.com/2012/10/19/questions-can-trigger-split-visit-charge-at-docs-office/

Image Methods Of Psychosocial Intervention 2 4 13-1As detailed in a CBS news story, a woman sought a physical examination from her primary care physician, after not receiving regular care for some time. She came prepared with a long list of health questions for which she would seek answers in her appointment. The physician obtained reimbursement from insurance for the physical by billing for all of the specific tests and procedures that had been done. However, he billed the woman by the minute for the discussion. A commentator in the news segment discussing this said, in effect, ‘physicians get paid for doing procedures, not for whether they solve problems and not for talking about it.”

Cancer care is expensive, which means lucrative for both for-profit and not-for-profit settings that can obtain reimbursement. There is increasing emphasis on procedures that are billable to third-party payers and for efficient use of providers’ time.   Provision of basic emotional support and time for patients discussing their concerns are endangered features of routine cancer care. But we should be careful about efforts to preserve these features by making them billable mental health procedures. That entails an inevitable need for a diagnosis and for rationing talk time, restricting it to those patients having a mental health related disorder.

More generally, psychotherapy intervention trials in cancer care do not typically attract patients with clinically significant distress in great numbers. Across trials, only about a third of the patients are clinically distressed. That is about the same as what you find in primary care medical population waiting rooms.

Correspondingly, RCTs of psychotherapy for cancer patients often failed to show a benefit because the patient samples that are recruited are overall insufficiently distressed. Why are the patients there, then?

It is likely that with the increasing scarcity of talk time in routine care, patients are simply seeking a safe place where they will be listened to, and can express and reflect on their feelings, not necessarily solve problems or reduce distress. That can be an entirely valid goal in itself. But problems arise when these discussions are of necessity provided as treatment with mental health professionals. Issues of cost effectiveness and efficacy arise, for which formal evidence is required. And such treatment is typically in short supply, with long waiting lists.

This RCT of dignity therapy came about because a  psychiatrist passionate about what he provides for palliative care patients developed and evaluated a structured mental health treatment. Maybe it is not all bad that the trial was negative. We now have a greater chance of preserving supportive elements of palliative care, including time for patients to talk about their concerns, and can hold off rationing them.