Clinical trial NCT06832605: Bounce-Back From Depression
Official title: Effectiveness and Cost-utility of Mindfulness-based Cognitive Therapy (MBCT) to Prevent Depressive Relapse or Recurrence in Spanish Adults With Recurrent Depressive Disorder: a Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Keywords: Depression
MBCT
Relapse/recurrence prevention
Cost-utility
RCT
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2025-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Time from randomisation to relapse or recurrence of major depression at 12-month follow-up
timeFrame: Through study completion, an average of 1 year after randomization
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)
timeFrame: Through study completion, an average of 1 year after randomization
measure: EuroQoL-5D (EQ-5D-5L)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Through study completion, an average of 1 year after randomization
Other outcomes:
measure: Sociodemographic-clinical data
timeFrame: Through study completion, an average of 1 year after randomization
measure: Brooding subscale of Ruminative Responses Scale-Short Form (RRS)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Decentering subscale of Experiences Questionnaire (EQ)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Sussex-Oxford Compassion Scale (SOCS-S)
timeFrame: Through study completion, an average of 1 year after randomization
measure: Ecological Momentary Assessment (EMA)
timeFrame: Daily for 8 weeks
measure: Mindfulness-Based Interventions-Participants; Assessment of Teaching (MBI:PAT)
timeFrame: Up to 8 weeks
measure: Mindfulness-Based Interventions Teaching Assessment Criteria (MBI-TAC)
timeFrame: Up to 8 weeks
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu (PSSJD)
state: Barcelona
city: Barcelona
country: Spain
facility: Parc de Salut Mar
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Fundació Sant Joan de Déu
name: Jesus Montero, PhD
role: PRINCIPAL_INVESTIGATOR
References: