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LIT-1223: Refractory depression – mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

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StatusActive — read 2026-10-29 (NOTE-1358) in full, from the CC BY published version in PubMed Central (PMC7282863); worth reading as the first multicentre randomised trial of RO DBT and the main controlled evidence for it: RO DBT plus usual care beat usual care on depression at the end of six months of therapy and not at the 12-month primary end-point or at 18 months, while flexibility and emotional coping stayed better from 12 months on. Read it knowing that it selected on refractory depression and never measured overcontrol, that it was underpowered by its own account (therapist correlation 0.14 against 0.025 assumed), that the developer trained the therapists and six of sixteen authors have a financial interest, that its abstract's "throughout" for the process gains is not what its Table 1 shows, and that its title's mechanisms are not analysed.
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Tagspsychopathology-and-treatment
Cited as “paper” byNOTE-1358 — Lynch et al. — RefraMED trial of RO DBT for refractory depression

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Lynch, T. R., Hempel, R. J., Whalley, B., Byford, S., Chamba, R., Clarke, P., Clarke, S., Kingdon, D. G., O’Mahen, H., Remington, B., Rushbrook, S. C., Shearer, J., Stanton, M., Swales, M., Watkins, A. & Russell, I. T. (2020). Refractory depression – mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms. British Journal of Psychiatry 216(4): 204–212. doi:10.1192/bjp.2019.53.

Read in full on 2026-10-29 (NOTE-1358).

Why this is here

A42 of the exchange cited the RefraMED trial as the main controlled evidence for RO DBT. Bears on CLAIM-349: the trial’s gain in flexibility without a lasting gain on the primary outcome is a caution on reading overcontrol as the whole of the problem.

Note of 2026-10-29: the trial’s monograph, read

The NIHR Efficacy and Mechanism Evaluation monograph of the same trial, LIT-1838, is read (NOTE-1421). Three points bear on this paper.

  • “Throughout.” The monograph’s Table 8 has the same 7-month differences in flexibility and emotional coping, with intervals about 1.8 times narrower, and finds them significant (AAQ-II p = 0.010, EAC p = 0.036), where this paper’s Table 1 has P = 0.096 and P = 0.132. So this paper’s abstract matches the monograph’s analysis and not its own table. The conflict is between two analyses of one data set; neither document says why the intervals differ. The status note’s caution stands for this paper.
  • The adverse reactions. The monograph gives “p < 0.01” where this paper gives one-tailed P = 0.004. Neither reproduces from the counts: with eight reactions in eight participants, P = C(162,8)/C(250,8) = 0.029, and larger if fewer participants were affected. The imbalance stays under 0.05.
  • The title’s “mechanisms”. The monograph reports the mediation analyses this paper omits. The mediators are sessions attended, therapeutic alliance and DBT skills; flexibility and emotional coping are not entered as mediators; mediator and outcome are both at 7 months; and the instrumented analysis failed on weak instruments (Cragg–Donald statistics no larger than 1). So the mechanism the title names is still not estimated.

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