How APA’s rating of acceptance and commitment therapy for psychosis got downgraded from “strong” to “modest” efficacy

dodosA  few years ago my blog post caused a downgrading of ACT for psychosis that stuck. This shows the meaninglessness of APA ratings of psychotherapies as evidence-supported.

Steve Hayes came into my twitter feed urging me to take a fresh look at the evidence for the efficacy of acceptance and commitment therapy (ACT).

I clicked on the link he provided and I was underwhelmed.

I was particularly struck by the ratings of ACT by the American Psychological Association Division 12.

I also noticed that ACT for psychosis was still rated only modestly supported.

A few years ago ACT was rated “strongly supported.” This rating was immediately downgraded to “modestly supported “by my exposing a single study as being p-hacked in a series of blog posts and in discussions on Facebook.

That incident sheds light on the invalidity of ratings by the American Psychological Association Division 12 of the evidence-supported status of therapies.

Steve Hayes’ Tweet

edited steve hayes exchange

Clicking on the link Hayes provided took me to

State of the ACT Evidence

 

ACBS

The APA ratings were prominently displayed above a continuously updated list of reviews and studies.

American Psychological Association, Society of Clinical Psychology (Div. 12), Research Supported Psychological Treatments:

Chronic Pain – Strong Research Support
Depression – Modest Research Support
Mixed anxiety – Modest Research Support
Obsessive-Compulsive Disorder – Modest Research Support
Psychosis – Modest Research Support
For more information on what the “modest” and “strong” labels mean, click here

Only ACT for Chronic Pain was rated as having strong support. But that rating seemed to be contradicted by the newest systematic review that was listed:

Simpson PA, Mars T, Esteves JE. A systematic review of randomised controlled trials using Acceptance and commitment therapy as an intervention in the management of non-malignant, chronic pain in adults. International Journal of Osteopathic Medicine. 2017 Jun 30;24:18-31.

That review was unable to provide a meta analysis because of the poor quality of the 10 studies that were available and their heterogeneity.

My previous complaints about how the evidence for treatments as evaluated by APA

There are low thresholds for professional groups such as the American Psychological Association Division 12 or governmental organizations such as the US Substance Abuse and Mental Health Services Administration (SAMHSA) declaring treatments to be “evidence-supported.” Seldom are any treatments deemed ineffective or harmful by these groups.

Professional groups have conflicts of interest in wanting their members to be able to claim the treatments they practice are evidence-supported, while not wanting to restrict practitioner choice with labels of treatment as ineffective. Other sources of evaluation like SAMHSA depend heavily and uncritically on what promoters of particular psychotherapies submit in applications for “evidence supported status.”

My account of how my blogging precipitated a downgrading of ACT for psychosis

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, 23) 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.”

My exposure of a small, but classic study of ACT for psychosis having been p-hacked

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.

  • 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.

Another study, which has been cited 64 times [at the time] 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.”

I noted at the time:

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.