Bounce-Back From Depression

Not Applicable

Not yet recruiting

• Conditions: Depression - Major Depressive Disorder

• Registration Number: NCT06832605
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

Objectives: To analyse the effectiveness of adding: (i) mindfulness-based cognitive therapy (MBCT) delivered through 8 videoconference group sessions (group MBCT), and (ii) MBCT delivered through a self-help manual and 3 low-intensity group support sessions (beginning, middle, and end of the program) via videoconference (supported MBCT self-help) to treatment as usual (TAU, normally maintenance antidepressant medication), for the treatment of patients with recurrent depression, compared with TAU alone. Furthermore, we will assess the cost-utility of group MBCT vs. supported MBCT self-help vs. TAU alone, identifying potential predictors and moderators of response, and exploring the mechanisms through which the interventions exert effects.

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=300) with recurrent depression and high risk of relapse 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). Secondaries: 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-utility ratios and mediation path-analyses will be estimated. Acceptability will be evaluated using qualitative methods.

Detailed Description

Depression is a prevalent mental health disorder, affecting around 10% of the Spanish population at least once in their lifetime. It is a recurrent condition with significant personal and societal costs. Despite available treatments, more than half of those affected experience multiple relapses, with higher risks after each episode. In Spain, antidepressants are commonly used for relapse prevention, but many patients prefer psychological treatments due to the side effects and low adherence associated with medication.

Mindfulness-Based Cognitive Therapy (MBCT) is a psychological intervention designed to prevent depressive relapse. It involves weekly two-hour sessions over two months. In other countries, particularly in the English-speaking world, MBCT has been shown to reduce relapse risk by 25%, making it a promising alternative or complement to long-term antidepressant use. MBCT helps patients recognize early signs of depression and manage negative thoughts, preventing the onset of new episodes. It has gained recognition in countries like the UK, where it is recommended for recurrent depression in public healthcare systems.

However, the effectiveness of MBCT for relapse prevention has not yet been fully evaluated in Spain through randomized clinical trials. This project aims to determine whether MBCT, added to usual treatment (TAU), is more effective than TAU alone in preventing depressive relapse or recurrence in Spanish adults with recurrent depression. The study will evaluate both in-person group MBCT sessions via videoconference and self-help formats, exploring their cost-utility, psychological mechanisms, and patient characteristics to identify those most likely to benefit from the therapy.

The Bounce-Back from Depression multicentre project will shed light on the application of MBCT in the Spanish context for the prevention of depressive relapse/recurrence. The use of different delivery formats will provide information about effectiveness, scalability, and cost-benefit.

Study Timeline

• Study First Submitted: 2025-01-09
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-05-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age over 18.
• Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD), in partial remission.
• Internet access (via smartphone and computer).
• Understanding of written and read Spanish language.

Exclusion Criteria

• Current severe MDD, current/past psychosis, bipolar disorder, history of schizophrenia, schizoaffective disorder, organic mental disorder, current severe substance abuse, organic brain damage, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical treatment or therapy.
• No experience in the use of new technologies (computers/smartphones).
• Previously completed mindfulness training or extensive experience in meditation (i.e., i.e., no experience in the use of new technologies).
• Concurrent psychotherapy.
• No experience in the use of new technologies (computers/smart phones).
• Previously completed mindfulness training or extensive meditation experience (i.e. courses, retreats, or regular meditation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time from randomisation to relapse or recurrence of major depression at 12-month follow-up	Through study completion, an average of 1 year after randomization	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 according to the Longitudinal Interval Follow-up Evaluation (LIFE), a form of the Structured Clinical Interview for DSM-5 (SCID) designed for longitudinal studies.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	Through study completion, an average of 1 year after randomization	Depressive symptoms
Beck Depression Inventory II (BDI-II)	Through study completion, an average of 1 year after randomization	Severity of depression
Positive and Negative Affect Schedule (PANAS)	Through study completion, an average of 1 year after randomization	Positive and Negative Affect
Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)	Through study completion, an average of 1 year after randomization	Mental well-being
EuroQoL-5D (EQ-5D-5L)	Through study completion, an average of 1 year after randomization	Health-related quality of life
Client Service Receipt Inventory (CSRI)	Through study completion, an average of 1 year after randomization	Use of health and social services

Trial Locations

Locations (3)

Parc Sanitari Sant Joan de Déu (PSSJD); 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain

Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain