Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference

NCT06832605 | Not Yet Recruiting DMC

• 1 other identifier: PI23/00021
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Major Depressive Disorder, Recurrent, in Remission

Keywords

Depression; MBCT; Relapse/recurrence prevention; RCT; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Time from randomisation to relapse or recurrence of major depression at 12-month follow-up

  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.

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

Secondary Outcomes (6)

• Hamilton Depression Rating Scale (HDRS)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• Patient Health Questionnaire (PHQ-9)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• EuroQoL-5D (EQ-5D-5L)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

Other Outcomes (6)

• Perseverative Thinking Questionnaire (PTQ)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• Five Facet Mindfulness Questionnaire-15 items version (FFMQ-15)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

• Experiences Questionnaire (EQ)

  Pre-treatment, 2 months post-treatment, and 6- and 12-month follow-ups

Study Arms (3)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

TAU will be delivered as it is in routine clinical practice.

Other: Treatment as Usual (TAU)

Supported Mindfulness-Based Cognitive Therapy Self-Help

ACTIVE COMPARATOR

Patients will continue receiving TAU at the same time.

Behavioral: Mindfulness-Based Cognitive Therapy Self-Help

Group Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

Patients will continue receiving TAU at the same time.

Behavioral: Group Mindfulness-Based Cognitive Therapy

Interventions

Group Mindfulness-Based Cognitive Therapy BEHAVIORAL

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.

Also known as: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)

Group Mindfulness-Based Cognitive Therapy

Mindfulness-Based Cognitive Therapy Self-Help BEHAVIORAL

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.

Also known as: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)

Supported Mindfulness-Based Cognitive Therapy Self-Help

Treatment as Usual (TAU) OTHER

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18.
• Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD).
• Current partial remission (no current depressive episode; a score ≥8 on the HDRS).
• Internet access (via smartphone or personal computer).
• Spanish literacy (spoken and written).

You may not qualify if:

• Current or past psychosis, bipolar disorder, a history of schizophrenia, schizoaffective disorder, organic mental disorder, current severe substance abuse, organic brain damage, pervasive developmental delay, persistent antisocial behaviour, recent (in past 3 months) self-injury requiring clinical management or therapy according to medical records and clinical judgment.
• Formal concurrent structured psychotherapy during the intervention period.
• No experience in the use of new technologies (smartphones or computers).
• Having completed a mindfulness-based structured training and/or extensive meditation experience (i.e., previous participation in meditation retreats (≥1) or regular (≥ weekly) meditation practice) in the previous year, or intending to commence meditation retreats or meditation practice during the study.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Carlos III Health Institute: collaborator

Study Sites (3)

Parc de Salut Mar

Barcelona, Barcelona, 08003, Spain

Location

Parc Sanitari Sant Joan de Déu (PSSJD)

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence; Depression

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jesus Montero, PhD

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus Montero, PhD

CONTACT

(34) 936 615 208 - 12733; jesus.montero@sjd.es

Jaime Navarrete, PhD

CONTACT

(34) 936 615 208 - 12734; jaime.navarrete@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher Miguel Servet (CP21/00080)

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (3)