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

August 28, 2026 updated by: Jesus Montero Marin, Fundació Sant Joan de Déu

Effectiveness and Cost-Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference in the Spanish National Health System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
    • Barcelona
      • Barcelona, Barcelona, Spain, 08003
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Fundacio Centre Higiene Mental Nou Barris
        • Contact:
      • Sant Boi de Llobregat, Barcelona, Spain, 08830
        • Recruiting
        • Parc Sanitari Sant Joan de Déu (PSSJD)
        • Contact:
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as Usual (TAU)
TAU will be delivered as it is in routine clinical practice.
Other: 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.
Active Comparator: Supported Mindfulness-Based Cognitive Therapy Self-Help
Patients will continue receiving TAU at the same time.
Behavioral: Mindfulness-Based Cognitive Therapy Self-Help
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.
Other Names:
  • Treatment as Usual (TAU)
  • Mindfulness Based Cognitive Therapy
Experimental: Group Mindfulness-Based Cognitive Therapy
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.
Other Names:
  • Treatment as Usual (TAU)
  • Mindfulness Based Cognitive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months
Time Frame: 6- and 12-month follow-ups
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.
6- and 12-month follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GRID-HAMD
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Depressive symptoms
Baseline, post-treatment, and 6- and 12-month follow-ups
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline
Depressive symptoms
Baseline
Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Negative Affect
Baseline, post-treatment, and 6- and 12-month follow-ups
Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Mental well-being
Baseline, post-treatment, and 6- and 12-month follow-ups
EuroQoL-5D (EQ-5D-5L)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Health-related quality of life
Baseline, post-treatment, and 6- and 12-month follow-ups
Client Service Receipt Inventory (CSRI)
Time Frame: Baseline, 12-month follow-ups
Use of health and social services
Baseline, 12-month follow-ups
Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Time Frame: Baseline, post-treatment, 6- and 12-month follow-ups
Depressive symptom severity Score range is 0-27, lower scores indicating lower depressive symptom severity.
Baseline, post-treatment, 6- and 12-month follow-ups

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire-15 items version (FFMQ-15)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Process measure: Mindfulness skills
Baseline, post-treatment, and 6- and 12-month follow-ups
Sussex-Oxford (Self-)Compassion Scale (SOCS-S)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Process measure: Self-compassion
Baseline, post-treatment, and 6- and 12-month follow-ups
Positive and Negative Affect Schedule (PANAS)
Time Frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Process measure: positive affect
Baseline, post-treatment, and 6- and 12-month follow-ups
Negative Effects Questionnaire (NEQ-20)
Time Frame: Post-treatment, and 6- and 12-month follow-ups (or after participant reported clinical deterioration)
Safety: unpleasant experiences and perceived harm Score ranges from 0-80, higher scores indicating more negative effects from treatment.
Post-treatment, and 6- and 12-month follow-ups (or after participant reported clinical deterioration)
LBEQ
Time Frame: Will be conducted at the 6- and 12-month follow-ups following the intervention.
Lasting adverse effects
Will be conducted at the 6- and 12-month follow-ups following the intervention.
Ecological Momentary Assessment (EMA)
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Collaborators

Carlos III Health Institute
Obra Social La Caixa, Spain

Investigators

  • Principal Investigator: Jesus Montero, PhD, Fundació Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI23/00021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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