PLOS blog post by James Coyne PhD, 7 December 2016: Danish RCT of cognitive behavior therapy for whatever ails your physician about you

I was asked by a Danish journalist to examine a randomized controlled trial (RCT) of cognitive behavior therapy (CBT) for functional somatic symptoms. I had not previously given the study a close look.

I was dismayed by how highly problematic the study was in so many ways.

I doubted that the results of the study showed any benefits to the patients or have any relevance to healthcare.

I then searched and found the website for the senior author’s clinical offerings.  I suspected that the study was a mere experimercial or marketing effort of the services he offered.

Overall, I think what I found hiding in plain sight has broader relevance to scrutinizing other studies claiming to evaluate the efficacy of CBT for what are primarily physical illnesses, not psychiatric disorders. Look at the other RCTs. I am confident you will find similar problems. But then there is the bigger picture…

[A controversial assessment ahead? You can stop here and read the full text of the RCT  of the study and its trial registration before continuing with my analysis.]

Schröder A, Rehfeld E, Ørnbøl E, Sharpe M, Licht RW, Fink P. Cognitive–behavioural group treatment for a range of functional somatic syndromes: randomised trial. The British Journal of Psychiatry. 2012 Apr 13:bjp-p.

A summary overview of what I found:
The RCT:

• Was unblinded to patients, interventionists, and to the physicians continuing to provide routine care.
• Had a grossly unmatched, inadequate control/comparison group that leads to any benefit from nonspecific (placebo) factors in the trial counting toward the estimated efficacy of the intervention.
• Relied on subjective self-report measures for primary outcomes.
  With such a familiar trio of design flaws, even an inert homeopathic treatment would be found effective, if it were provided with the same positive expectations and support as the CBT in this RCT. [This may seem a flippant comment that reflects on my credibility, not the study. But please keep reading to my detailed analysis where I back it up.]
• The study showed an inexplicably high rate of deterioration in both treatment and control group. Apparent improvement in the treatment group might only reflect less deterioration than in the control group.

The study is focused on unvalidated psychiatric diagnoses being applied to patients with multiple somatic complaints, some of whom may not yet have a medical diagnosis, but most clearly had confirmed physical illnesses.
But wait, there is more!

It’s not CBT that was evaluated, but a complex multicomponent intervention in which what was called CBT is embedded in a way that its contribution cannot be evaluated.
The “CBT” did not map well on international understandings of the assumptions and delivery of CBT. The complex intervention included weeks of indoctrination of the patient with an understanding of their physical problems that incorporated simplistic pseudoscience before any CBT was delivered. We focused on goals imposed by a psychiatrist that didn’t necessarily fit with patients’ sense of their most pressing problems and the solutions.

And the kicker.

The authors switched primary outcomes – reconfiguring the scoring of their subjective self-report measures years into the trial, based on a peeking at the results with the original scoring.

Investigators have a website which is marketing services. Rather than a quality contribution to the literature, this study can be seen as an experimercial doomed to bad science and questionable results from before the first patient was enrolled. An undeclared conflict of interest in play? There is another serious undeclared conflict of interest for one of the authors.

For the uninformed and gullible, the study handsomely succeeds as an advertisement for the investigators’ services to professionals and patients.

Personally, I would be indignant if a primary care physician tried to refer me or friend or family member to this trial. In the absence of overwhelming evidence to the contrary, I assume that people around me who complain of physical symptoms have legitimate physical concerns. If they do not yet have a confirmed diagnosis, it serves little purpose to stop the probing and refer them to psychiatrists. This trial operates with an anachronistic Victorian definition of psychosomatic condition.