PPubMed15 Feb 2019Cited 32×

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

Thomas R. Lynch, Roelie J. Hempel, Ben Whalley, Sarah Byford, Rampaul Chamba, Paul Clarke, Susan Clarke, David G. Kingdon, Heather O'Mahen, Bob Remington, Sophie C. Rushbrook, James Shearer, Maggie Stanton, Michaela Swales, Alan Watkins, Ian T. Russell

Abstract

In participants with refractory depression, RO DBT was not statistically superior to TAU on the HRSD at our primary end-point of 12 months after randomisation, despite achieving the target moderate effect size of 0.40. However, it was substantially better than TAU immediately after treatment, with an effect size of 1.03, much larger than reported by previous trials of psychotherapy for refractory depression.4 The later fall in effect size stems from rapid improvement during RO DBT, and initially slow but accelerating improvement during TAU. Bayesian analysis post hoc generated ‘positive’ evide

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RO DBT lowered depression scores after 7 months but showed no lasting advantage over treatment as usual, with more serious adverse reactions reported.

What’s new

i.First randomized controlled trial evaluating RO DBT for refractory depression
ii.Demonstrated a large short‑term effect (5.40‑point HRSD reduction) after 7 months
iii.Showed increased serious adverse reactions in the RO DBT group
iv.Provided evidence of improved psychological flexibility and emotional coping

How they did it

The study randomly assigned 250 adults with refractory depression to either RO DBT plus treatment‑as‑usual (162 participants) or treatment‑as‑usual alone (88 participants). RO DBT consisted of 29 individual sessions and 27 skills‑class sessions over six months, and outcomes were assessed masked at 7, 12 and 18 months using the Hamilton Rating Scale for Depression and other measures, analyzed with linear mixed‑effects models.

What they found

At 7 months RO DBT reduced HRSD scores by 5.40 points versus TAU (95% CI 0.94‑9.85)
At 12 months the HRSD difference was 2.15 points (95% CI ‑2.28‑6.59), not statistically significant
At 18 months the HRSD difference was 1.69 points (95% CI ‑2.84‑6.22), not statistically significant
Eight serious adverse reactions occurred in the RO DBT group and none in the control group
Full remission rates were low (1% vs 0% at 7 months, 8% vs 0% at 12 months, 7% vs 1% at 18 months)
Partial remission rates were higher for RO DBT (23%, 26%, 33%) than control (6%, 22%, 24%)
Psychological flexibility and emotional coping improved significantly in the RO DBT group throughout the trial

Caveats

✕Variability in definitions of refractory and treatment‑resistant depression limits generalisability
✕Did not reach the planned sample size (250 recruited of 276 target) and analysed only 190 participants
✕Unexpected therapist heterogeneity affected outcomes
✕Loss of power after month 7 prevented statistical significance for later time points

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