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Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
Sponsor: Fundació Sant Joan de Déu
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2026-04
Completion Date
2028-06
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
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.
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.
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.
Locations (3)
Parc de Salut Mar
Barcelona, Barcelona, Spain
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain