Overview
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, either in an acute episode or in 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), Hospital del Mar (Barcelona), Fundació Centre Higiene Mental Nou Barris (Barcelona), and Hospital General Universitario de Elche (Elche, Alicante). Participants: Adult patients (n=342) with recurrent depression, either in an acute episode or in remission, will be randomly assigned to group MBCT, supported MBCT self-help, or TAU. Primary outcome: transitions between clinically defined states of recurrent depression over the 12-month follow-up (DSM-5). The primary confirmatory transition is from remission to a major depressive episode (relapse/recurrence), whereas the transition from acute depression to remission will be examined as an exploratory objective. Secondary outcomes: depressive symptom severity, negative affect, mental well-being, quality of life, costs, and quality-adjusted life years. Process measures: mindfulness, positive affect, and self-compassion. Main statistical analyses: The primary analysis will use the intention-to-treat (ITT) principle and continuous-time multi-state modelling to estimate transition-specific hazard ratios. Secondary outcomes, predictors, and moderators will be analysed using regression-based approaches. Cost-effectiveness and cost-utility analyses will be conducted from healthcare system and societal perspectives, alongside mediation analyses. Participant experiences 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 comparison of two delivery formats will provide evidence on effectiveness, cost-effectiveness, scalability, and efficient resource allocation.
Description
The BECOME trial was developed to fill an important evidence gap on whether Mindfulness-Based Cognitive Therapy (MBCT) is clinically effective and cost-effective across different stages of recurrent depression within the Spanish National Health System (NHS). While MBCT has strong evidence as an alternative to maintenance antidepressant medication (m-ADM) for people with recurrent depression, most of this research has been conducted outside Spain and has not been confirmed in a sufficiently powered, multicentre randomized controlled trial in the Spanish setting. This gap is especially relevant in the post-COVID-19 period, when depressive disorders have increased in prevalence and severity, adding pressure to already overstretched public mental health services. Recurrent depression also carries a high social and economic burden in Spain, making the identification of effective, scalable, and sustainable interventions to improve outcomes across the clinical trajectory of recurrent depression a public health priority. Most prior studies have focused on face-to-face MBCT and have given limited attention to implementation constraints in publicly funded systems. In addition, many patients report concerns about long-term antidepressant use (e.g., side effects and adherence difficulties) and often prefer psychological approaches, highlighting the need to evaluate acceptable and accessible alternatives such as MBCT. By comparing videoconference-delivered group MBCT and supported MBCT self-help against treatment as usual (TAU), this study aims to provide pragmatic evidence on whether different MBCT delivery formats can broaden access to individuals across the clinical trajectory of recurrent depression while preserving clinical benefit and good value for money in routine services. The trial will also assess outcomes from both healthcare and societal perspectives, which is important given the significant indirect costs of recurrent depression in Spain, including work disability and reduced productivity. As digitally supported care becomes more common, rigorous evaluation of its clinical and economic impact is essential to ensure that digital delivery improves outcomes and delivers measurable public health value.
Eligibility
Inclusion Criteria:
- Age over 18.
- Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD), either in an acute mild/moderate episode or in remission.
- Internet access (via smartphone or personal computer).
- Spanish literacy (spoken and written).
Exclusion Criteria:
- Current severe depressive episode (≥24 on the GRID-HAMD)
- Current or past psychosis, bipolar 1 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 the past 6 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.
