Summary
Background
Individuals
with a history of recurrent depression have a high risk of repeated
depressive relapse or recurrence. Maintenance antidepressants for at
least 2 years is the current recommended treatment, but many individuals
are interested in alternatives to medication. Mindfulness-based
cognitive therapy (MBCT) has been shown to reduce risk of relapse or
recurrence compared with usual care, but has not yet been compared with
maintenance antidepressant treatment in a definitive trial. We aimed to
see whether MBCT with support to taper or discontinue antidepressant
treatment (MBCT-TS) was superior to maintenance antidepressants for
prevention of depressive relapse or recurrence over 24 months.
Methods
In
this single-blind, parallel, group randomised controlled trial
(PREVENT), we recruited adult patients with three or more previous major
depressive episodes and on a therapeutic dose of maintenance
antidepressants, from primary care general practices in urban and rural
settings in the UK. Participants were randomly assigned to either
MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a
computer-generated random number sequence with stratification by centre
and symptomatic status. Participants were aware of treatment allocation
and research assessors were masked to treatment allocation. The primary
outcome was time to relapse or recurrence of depression, with patients
followed up at five separate intervals during the 24-month study period.
The primary analysis was based on the principle of intention to treat.
The trial is registered with Current Controlled Trials, ISRCTN26666654.
Findings
Between
March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for
eligibility and recruited 424 patients from 95 general practices. 212
patients were randomly assigned to MBCT-TS and 212 to maintenance
antidepressants. The time to relapse or recurrence of depression did not
differ between MBCT-TS and maintenance antidepressants over 24 months
(hazard ratio 0·89, 95% CI 0·67–1·18; p=0·43), nor did the number of
serious adverse events. Five adverse events were reported, including two
deaths, in each of the MBCT-TS and maintenance antidepressants groups.
No adverse events were attributable to the interventions or the trial.
Interpretation
We
found no evidence that MBCT-TS is superior to maintenance
antidepressant treatment for the prevention of depressive relapse in
individuals at risk for depressive relapse or recurrence. Both
treatments were associated with enduring positive outcomes in terms of
relapse or recurrence, residual depressive symptoms, and quality of
life.
Funding
National Institute for
Health Research (NIHR) Health Technology Assessment (HTA) programme, and
NIHR Collaboration for Leadership in Applied Health Research and Care
South West Peninsula.
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