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LIT-1838: Radically open dialectical behaviour therapy for refractory depression: the RefraMED RCT

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StatusActive — read 2026-10-29 (NOTE-1421) in full, from the NIHR Journals Library's own PDF (open access); worth reading as the full report of the RefraMED trial and the only place its mechanism analysis is given: a trial that randomised RO DBT participants to three non-therapeutic features (therapy room, written feedback, mode of reimbursement) and to therapists, to serve as instruments for exposure, alliance and skills. The instruments were weak (Cragg–Donald statistics at most 1) and, by the authors' own account, the instrumented estimates mean nothing. Read it knowing that the analysed mediators are sessions attended, alliance and DBT skills, not the flexibility and emotional-coping measures, that the mediators and the outcome are both at 7 months, that the unadjusted decompositions put the indirect effect several times the total with a direct effect of the opposite sign, that the planned analyses of temporal order were not reported, that its process-measure intervals are about half as wide as the BJP paper's for the same differences, and that its adverse-event test (one-tailed Fisher, p < 0.01) does not reproduce from its own counts.
Version2
Tagspsychopathology-and-treatment, causality
Cited as “paper” byNOTE-1421 — Lynch et al. — RefraMED, the NIHR EME monograph

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Lynch, T. R., Hempel, R. J., Whalley, B., Byford, S., Chamba, R., Clarke, P., Clarke, S., Kingdon, D., O’Mahen, H., Remington, B., Rushbrook, S. C., Shearer, J., Stanton, M., Swales, M., Watkins, A. & Russell, I. T. (2018). Radically open dialectical behaviour therapy for refractory depression: the RefraMED RCT. Efficacy and Mechanism Evaluation, 5(7). NIHR Journals Library.

Read in full on 2026-10-29 (NOTE-1421).

Why this is here

The triage of 2026-10-29 put it in the File tier. The record holds the trial through its journal paper, LIT-1223, read in NOTE-1358, which found that the title’s mechanisms are not analysed and that the paper refers to this report for adverse-event monitoring. Two entries wait on it. QUESTION-045 asks whether a disorder that outlasts its trigger is a protective lock-in, and its note of 2026-10-29 found nothing on mechanism in the BJP paper. QUESTION-292, answered by THEORY-053, says what would count: change in the theorised process that is specific to it and comes before the outcome. This report is where the trial’s causal mechanism analysis is given, and where its adverse-event figures can be checked against the P = 0.004 that NOTE-1358 could not reproduce.

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