An interventional study of Group Mindfulness-Based Cognitive Therapy and Mindfulness-Based Cognitive Therapy Self-Help in Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild and Major Depressive Disorder, Recurrent, Moderate, sponsored by Fundació Sant Joan de Déu. Recruiting at 5 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 342 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
TAU will be delivered as it is in routine clinical practice.
Other: Treatment as Usual (TAU)
Patients will continue receiving TAU at the same time.
Behavioral: Mindfulness-Based Cognitive Therapy Self-Help
Patients will continue receiving TAU at the same time.
Behavioral: Group Mindfulness-Based Cognitive Therapy
Videoconference-delivered group MBCT will be provided in line with the manual 'Mindfulness-Based Cognitive Therapy for Depression'. The program will be led by Spanish MBCT therapists who are trained and certified, and who will also complete a 2-day study standardisation course. After this training, therapists must demonstrate at least "competent" teaching skills, confirmed by an independent assessor using the Mindfulness-Based Interventions Teaching Assessment Criteria (MBI:TAC). Competency will be defined as a score of 4-6 based on the rating of a randomly selected recorded session. Group MBCT is a structured mindfulness meditation program designed to help participants learn skills to reduce the risk of depression relapse or recurrence. It will be delivered over 8 weeks in weekly group sessions lasting 2 hours, with approximately 12 participants per group, and includes between-session home practice.
Also known as: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)
Participants work through the Spanish version of 'The Mindful Way Workbook: An 8-Week Program to Free Yourself from Depression and Emotional Distress' on their own, following weekly instructions and mindfulness exercises. The workbook presents the standard 8-week MBCT program in a self-guided format. It also includes reflection questions, tools to monitor progress, and feedback from people who have previously completed the program. To support engagement and manage difficulties, participants will also take part in three structured, low-intensity group support sessions with a health psychologist (at the start, mid-point, and end of the program). Each session will last 1 hour, be delivered by group videoconference, and include approximately 12 participants per group.
Also known as: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)
TAU (treatment as usual) will be delivered as it is in routine clinical practice. In Spain, ongoing care for recurrent depression commonly relies on maintenance antidepressant medication (m-ADM). Spanish National Health System guidelines recommend continuing antidepressants for at least two years at the same dose that was effective during the acute treatment phase. Participants will be advised that, if they notice a worsening of symptoms or encounter difficulties during the study, they should seek help from their primary care General Practitioner or their usual mental health service provider, as they would normally do.
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months
The primary outcome will be transitions between clinically defined states of recurrent depression over the 12-month follow-up, assessed in a time-to-event analysis. 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. The presence of depression between assessments will be assessed retrospectively according to the Longitudinal Interval Follow-up Evaluation (LIFE), a form of the Structured Clinical Interview for DSM-5 (SCID) designed for longitudinal studies.
Time frame: 6- and 12-month follow-ups
GRID-HAMD
Depressive symptoms
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Patient Health Questionnaire (PHQ-9)
Depressive symptoms
Time frame: Baseline
Positive and Negative Affect Schedule (PANAS)
Negative Affect
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)
Mental well-being
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
EuroQoL-5D (EQ-5D-5L)
Health-related quality of life
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Client Service Receipt Inventory (CSRI)
Use of health and social services
Time frame: Baseline, 12-month follow-ups
Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Depressive symptom severity Score range is 0-27, lower scores indicating lower depressive symptom severity.
Time frame: Baseline, post-treatment, 6- and 12-month follow-ups
Five Facet Mindfulness Questionnaire-15 items version (FFMQ-15)
Process measure: Mindfulness skills
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Sussex-Oxford (Self-)Compassion Scale (SOCS-S)
Process measure: Self-compassion
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Positive and Negative Affect Schedule (PANAS)
Process measure: positive affect
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Negative Effects Questionnaire (NEQ-20)
Safety: unpleasant experiences and perceived harm Score ranges from 0-80, higher scores indicating more negative effects from treatment.
Time frame: Post-treatment, and 6- and 12-month follow-ups (or after participant reported clinical deterioration)
LBEQ
Lasting adverse effects
Time frame: Will be conducted at the 6- and 12-month follow-ups following the intervention.
Ecological Momentary Assessment (EMA)
The m-Path platform will be used to assess the fluctuation of depressed mood and anhedonia, present-moment attention, non-judgmental acceptance, positive affect, negative affect, daily hassles, and home-based mindfulness practice and treatment integration.
Time frame: One-week baseline period prior to the start of the intervention, the 8-week duration of the active intervention period, and during a one-week post-intervention period
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD and supporting information will be made available upon reasonable request after study completion and dissemination of primary, secondary, and exploratory planned analyses.
Access criteria: Qualified researchers whose proposals have received approval from an appropriate institutional research ethics committee. They will be able to access IPD and supporting information.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 18 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
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Fundació Sant Joan de Déu