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NCT06832605: BECOME
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
NA trial testing Group Mindfulness-Based Cognitive Therapy in Major Depressive Disorder, Recurrent, in Remission in 315 participants. Not yet recruiting.
1 December 2027
Quick facts
| Lead sponsor | Fundació Sant Joan de Déu |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 315 |
| Start date | 1 April 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 June 2028 |
| Sites | 3 locations across Spain |
Drugs / interventions tested
- Group Mindfulness-Based Cognitive Therapy
- Mindfulness-Based Cognitive Therapy Self-Help
- Treatment as Usual (TAU) — full drug profile →
Conditions studied
- Major Depressive Disorder, Recurrent, in Remission — all drugs for Major Depressive Disorder, Recurrent, in Remission →
Sponsor
Fundació Sant Joan de Déu — full company profile →
Who can join
18 and older, any sex, with Major Depressive Disorder, Recurrent, in Remission. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time from randomisation to relapse or recurrence of major depression at 12-month follow-up
Time frame: Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups
The primary outcome will be the time from randomisation to relapse or recurrence of major depression at 12-month follow-up, assessed in a time-to-event analysis, with patients followed at 3 different intervals during the study period (post-treatment, as well as 6-month and 12-month follow-up after randomisation). The presence of depression between assessments will be assessed retrospectively accor
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06832605
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06832605 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Sant Joan de Déu
- Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06832605.
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