Staying well after depression: trial design and protocol

Relapse rates for recurrent depression range from 50-80%, and the risk is especially high for people who become suicidal when depressed. This trial compares Mindfulness-Based Cognitive Therapy (MBCT), which combines mindfulness meditation with cognitive therapy, against Cognitive Psycho-Education (CPE), a cognitive treatment without meditation, and treatment as usual (TAU). Participants with recurrent depression are randomly assigned to MBCT plus TAU, CPE plus TAU, or TAU alone in a 2:2:1 ratio, with a target of 300 participants after attrition. Both active treatments are delivered in weekly two-hour group sessions for eight weeks. Effects on relapse and suicidal symptoms will be measured over 12 months, with assessments immediately after treatment and at three, six, nine, and twelve months.

Study at a glance

Abstract

Abstract Background Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. Methods/Design This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. Discussion This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression - that in people who become suicidal when depressed. Trial Registration Current Controlled Trials: ISRCTN97185214.