Not Yet RecruitingNot Applicable

Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference

Spain315 participantsStarted 2026-04

Plain-language summary

Objectives: To evaluate the clinical- and cost-effectiveness of two delivery formats of mindfulness-based cognitive therapy (MBCT) - (i) MBCT delivered through eight videoconference group sessions (group MBCT), and (ii) MBCT delivered through a self-help manual plus three low-intensity videoconference group support sessions (supported MBCT self-help) - when added to treatment as usual (TAU; mental health outpatient care), compared with TAU alone, in patients with recurrent depression in partial remission. We will identify potential predictors and moderators of response and examine psychological mechanisms of change. Study design: Multicentre randomised controlled trial, with pre-post, 6- and 12-months follow-ups. Centres: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat), Hospital Universitario Miguel Servet (Zaragoza), and Hospital del Mar (Barcelona). Participants: Adult patients (n=315) with recurrent depression in partial remission will be randomly assigned to group MBCT, supported MBCT self-help, or TAU. Primary outcome: time from randomisation to depressive relapse/recurrence at 12-month follow-up (DSM-5). Secondary outcomes: residual symptoms, well-being, quality of life, costs, and quality-adjusted life years. Process measures: rumination, mindfulness, decentering, affectivity, and self-compassion. Main statistical analyses: Hazard ratios will be calculated using survival analysis. Secondary outcomes, predictors, and moderators will be tested using regression-based approaches. Incremental cost-effectiveness ratios from healthcare system and societal perspectives will be estimated, alongside mediation analyses. Expectations and acceptability will be evaluated using qualitative methods. Conclusions: This study will inform the implementation of two accessible MBCT formats in Spain for preventing depressive relapse/recurrence. The use of different delivery formats will provide information on effectiveness, scalability, and value for money.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age over 18. * Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD). * Current partial remission (no current depressive episode; a score ≥8 on the HDRS). * Internet access (via smartphone or personal computer). * Spanish literacy (spoken and written). Exclusion Criteria: * Current or past psychosis, bipolar disorder, a history of schizophrenia, schizoaffective disorder, organic mental disorder, current severe substance abuse, organic brain damage, pervasive developmental delay, persistent antisocial behaviour, recent (in past 3 months) self-injury requiring clinical management or therapy according to medical records and clinical judgment. * Formal concurrent structured psychotherapy during the intervention period. * No experience in the use of new technologies (smartphones or computers). * Having completed a mindfulness-based structured training and/or extensive meditation experience (i.e., previous participation in meditation retreats (≥1) or regular (≥ weekly) meditation practice) in the previous year, or intending to commence meditation retreats or meditation practice during the study.

What they're measuring

Time from randomisation to relapse or recurrence of major depression at 12-month follow-up

Timeframe: Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

Trial details

NCT IDNCT06832605

SponsorFundació Sant Joan de Déu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Jesus Montero, PhD

(34) 936 615 208 - 12733 jesus.montero@sjd.es