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The REFRAMED trial

November 2, 2013

Can true believers get at the truth?

The UK Medical Research Council (MRC) is currently spending over £2M on a randomised trial evaluating a newish type of talking therapy, Radically Open Dialectical Behaviour Therapy (RO-DBT), to treat chronic depression.

As you’d expect from the MRC, the trial is well designed. Registered here, participants are allocated at random to either RO-DBT-plus-anti-depressants, or to anti-depressants alone.  The sample size is 276, and the primary outcome is the Hamilton Rating Scale.

But there is a problem. The researchers appear to be true believers in the treatment, and since participants know what group they are in, their responses are likely to be influenced by the researchers enthusiasm.

The acronym, REFRAMED, (REFRActory depression – Mechanisms and Evaluation of DBT) should set alarm bells ringing.  It implies that the treatment is going to do something dramatic for this tragic group of patients.  It might, but it might be ineffective or do harm. That’s why they’re doing a randomised trial

But it gets worse. The trial website (click here), which is designed to identify potential participants and support those who have already joined, is openly biased.   Here’s a couple of sentences from the front page:

80% of participants who have completed the DBT treatment say they would recommend the treatment to a friend

66% of participants in the DBT group found the treatment very helpful, and say they have learnt a lot of new skills.

Click on the button to find out more and you come across these participant testimonials:

“I was anxious before the assessment but I was keen to be assessed and really happy to get into the DBT treatment group. I found the assessment very helpful. It was great to talk to someone about my mental health issues. I was happy to spend the length of the time of the assessment to create a clear picture of my health. The assessor was very understanding and made me feel relaxed.”

“DBT has changed my life dramatically. I am no longer depressed and have the ability of choice in my life. Before DBT I was very fixed and was in a deep depression, unable to make the changes I so desperately needed.”

There’s also a link to a radio interview with Thomas R. Lynch, the developer of the therapy and the trial chief investigator, during which two patient testimonies are read out by actors.

“I needed and wanted a dramatic change in my life to pull me out of my depression. If it hadn’t have been as successful, I wouldn’t be here today. I manage my depression well and can see early signs of depression so now I can prevent myself going downhill and use the skills I’ve been taught.

“I’m no longer depressed and have the ability of choice in my life. Before RO-DBT I was very fixed and was in a deep depression and unable to make the changes I so desperately needed.”

The interview ends with Dr Lynch directing potential participants to the trial website.

If someone ran an anti-depressant drug trial this way, telling participants that they were getting the active treatment and giving them testimonies from successfully treated patients we would regard them as charlatans.

Of course a trial of a talking therapy cannot be completely double blind. The therapist knows what treatment they are giving and the patient knows that they are getting talking therapy. But researchers should still try to minimise non treatment-related differences between the groups. Ideally trials like this should be run by neutral researchers. Perhaps it’s too late for that now. but at the very least the biased information should be removed from the website.

This is not some amateur trial being run on a shoestring. The taxpayer is paying £2M. That’s over £7,000 per patient recruited! It should be done right.

Jim Thornton

One Comment leave one →
  1. December 4, 2013 5:45 pm

    4 December 2013 update. Professor Lynch has contacted me and updated the REFRAMED website to remove the potentially biasing testimionials. Thank you. I think this will reduce the chance of getting a false postive result from this trial.

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