RecruitingNot applicableEN original

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

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About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek powyżej 18 lat
  • •Postawienie diagnozy nawracającej depresji (co najmniej 2 poprzednie epizody)
  • •Obecny stan: lekka/umiarkowana depresja lub okres remisji (bez objawów)
  • •Dostęp do internetu przez smartphone'a lub komputer
  • •Umiejętność czytania i mówienia po hiszpańsku

✗ Disqualifies

  • •Obecnie ciężka depresja wymagająca natychmiastowej interwencji
  • •Obecne lub przeszłe psychozy, choroba afektywna dwubiegunowa typu 1, schizofrenia lub zaburzenia pokrewne
  • •Aktualny poważny problem z uzależnieniem od substancji
  • •Zaburzenia rozwojowe lub uszkodzenia mózgu
  • •Aktualna terapia psychologiczna prowadzona równocześnie z badaniem
  • •Brak doświadczenia w obsłudze urządzeń technologicznych
  • •Poprzednie zaawansowane praktyki medytacji w ciągu ostatniego roku

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 3, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

Hospital General Universitario de Elche

Elche, Spain

Parc de Salut Mar

Barcelona, Spain

Fundacio Centre Higiene Mental Nou Barris

Barcelona, Spain

Parc Sanitari Sant Joan de Déu (PSSJD)

Sant Boi de Llobregat, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/4/2026.

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