Bounce-Back From Depression

NCT ID: NCT06832605

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-31

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.

Conditions

Depression - Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment as Usual (TAU)

TAU is administered in current daily practice and is defined as instructing participants to consult their family doctor or usual healthcare professional, as they normally would, if they experience symptomatic deterioration or difficulties during the study.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: OTHER

Standard pharmacological treatment usually provided to patients suffering depression.

MBCT self-help

The 'MBCT self-help' is based on the book 'The Mindfulness Way: An 8-week plan to free yourself from depression and emotional stress'. The book presents the 8-week MBCT course as a self-help booklet. Participants are asked to guide themselves using the self-help book. The book provides elaborate and practical mindfulness guidelines that can be exercised each week, as well as questions to help with reflection, ways to check progress and valuable feedback from others who have undertaken this MBCT programme.

Group Type: EXPERIMENTAL

MBCT self-help

Intervention Type: BEHAVIORAL

The 'MBCT self-help' is based on the book 'The Mindfulness Way: An 8-week plan to free yourself from depression and emotional stress'. The book presents the 8-week MBCT course as a self-help booklet. Participants are asked to guide themselves using the self-help book. The book provides elaborate and practical mindfulness guidelines that can be exercised each week, as well as questions to help with reflection, ways to check progress and valuable feedback from others who have undertaken this MBCT programme.

Standard pharmacological treatment usually provided to patients suffering depression.

Group MBCT

Group MBCT' will follow the treatment manual "Mindfulness-Based Cognitive Therapy for Depression". Group MBCT' is a systematic training in mindfulness meditation techniques to teach participants skills to prevent relapse/recurrence of depression. Treatment includes weekly 2-hour classes over an 8-week period with home exercises, a full day of practice (6 hours long, adapted for online delivery), and 4 booster sessions offered every 3 months from the start of the programme.

Group Type: EXPERIMENTAL

MBCT group

Intervention Type: BEHAVIORAL

MBCT is a systematic training in mindfulness meditation techniques to teach participants skills to prevent relapse/recurrence of depression. Treatment includes weekly 2-hour classes over an 8-week period with home exercises, a full day of practice (6 hours long, adapted for online delivery), and 4 booster sessions offered every 3 months from the start of the programme.

Standard pharmacological treatment usually provided to patients suffering depression.

Interventions

MBCT group

MBCT is a systematic training in mindfulness meditation techniques to teach participants skills to prevent relapse/recurrence of depression. Treatment includes weekly 2-hour classes over an 8-week period with home exercises, a full day of practice (6 hours long, adapted for online delivery), and 4 booster sessions offered every 3 months from the start of the programme.

Standard pharmacological treatment usually provided to patients suffering depression.

Intervention Type: BEHAVIORAL

MBCT self-help

The 'MBCT self-help' is based on the book 'The Mindfulness Way: An 8-week plan to free yourself from depression and emotional stress'. The book presents the 8-week MBCT course as a self-help booklet. Participants are asked to guide themselves using the self-help book. The book provides elaborate and practical mindfulness guidelines that can be exercised each week, as well as questions to help with reflection, ways to check progress and valuable feedback from others who have undertaken this MBCT programme.

Standard pharmacological treatment usually provided to patients suffering depression.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to patients suffering depression.

Intervention Type: OTHER

Other Intervention Names

Mindfulness Based Cognitive Therapy; Treatment as Usual (TAU); Mindfulness Based Cognitive Therapy; Treatment as Usual (TAU)

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos III Health Institute

OTHER_GOV

Sponsor Role: collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Jesus Montero Marin

Senior Researcher Miguel Servet (CP21/00080)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesus Montero, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Sant Joan de Déu

Locations

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

Countries

Spain

Central Contacts

Jesus Montero, PhD

Role: CONTACT

jesus.montero@sjd.es

(34) 936 615 208 - 12733

Jaime Navarrete, PhD

Role: CONTACT

jaime.navarrete@sjd.es

(34) 936 615 208 - 12734

Other Identifiers

PI23/00021

Identifier Type: -

Identifier Source: org_study_id