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

NCT06832605

RecruitingNA

Sponsor: Fundació Sant Joan de Déu

Conditions: Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild, Major Depressive Disorder, Recurrent, Moderate

Interventions: Group Mindfulness-Based Cognitive Therapy, Mindfulness-Based Cognitive Therapy Self-Help, Treatment as Usual (TAU)

Countries: Spain

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, either in an acute episode or in 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), Hospital del Mar (Barcelona), Fundació Centre Higiene Mental Nou Barris (Barcelona), and Hospital General Universitario de Elche (Elche, Alicante). Participants: Adult patients (n=342) with recurrent depression, either in an acute episode or in remission, will be randomly assigned to group MBCT, supported MBCT self-help, or TAU. Primary outcome: transitions between clinically defined states of recurrent depression over the 12-month follow-up (DSM-5). The primary confirmatory transition is from remission to a major depressive episode (relapse/recurrence), whereas the transition from acute depression to remission will be examined as an exploratory objective. Secondary outcomes: depressive symptom severity, negative affect, mental well-being, quality of life, costs, and quality-adjusted life years. Process measures: mindfulness, positive affect, and self-compassion. Main statistical analyses: The primary analysis will use the intention-to-treat (ITT) principle and continuous-time multi-state modelling to estimate transition-specific hazard ratios. Secondary outcomes, predictors, and moderators will be analysed using regression-based approaches. Cost-effectiveness and cost-utility analyses will be conducted from healthcare system and societal perspectives, alongside mediation analyses. Participant experiences 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 comparison of two delivery formats will provide evidence on effectiveness, cost-effectiveness, scalability, and efficient resource allocation.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Age over 18.
* Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD), either in an acute mild/moderate episode or in remission.
* Internet access (via smartphone or personal computer).
* Spanish literacy (spoken and written).

Exclusion Criteria:

* Current severe depressive episode (≥24 on the GRID-HAMD)
* Current or past psychosis, bipolar 1 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 the past 6 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.
Locations (5)
  • Elche, Alicante, Spain
  • Barcelona, Barcelona, Spain
  • Barcelona, Barcelona, Spain
  • Sant Boi de Llobregat, Barcelona, Spain
  • Zaragoza, Zaragoza, Spain