Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild, Major Depressive Disorder, Recurrent, Moderate
Conditions
Keywords
Depression, MBCT, Relapse/recurrence prevention, RCT, cost-effectiveness
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, 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.
Detailed description
The BECOME trial was developed to fill an important evidence gap on whether Mindfulness-Based Cognitive Therapy (MBCT) is clinically effective and cost-effective across different stages of recurrent depression within the Spanish National Health System (NHS). While MBCT has strong evidence as an alternative to maintenance antidepressant medication (m-ADM) for people with recurrent depression, most of this research has been conducted outside Spain and has not been confirmed in a sufficiently powered, multicentre randomized controlled trial in the Spanish setting. This gap is especially relevant in the post-COVID-19 period, when depressive disorders have increased in prevalence and severity, adding pressure to already overstretched public mental health services. Recurrent depression also carries a high social and economic burden in Spain, making the identification of effective, scalable, and sustainable interventions to improve outcomes across the clinical trajectory of recurrent depression a public health priority. Most prior studies have focused on face-to-face MBCT and have given limited attention to implementation constraints in publicly funded systems. In addition, many patients report concerns about long-term antidepressant use (e.g., side effects and adherence difficulties) and often prefer psychological approaches, highlighting the need to evaluate acceptable and accessible alternatives such as MBCT. By comparing videoconference-delivered group MBCT and supported MBCT self-help against treatment as usual (TAU), this study aims to provide pragmatic evidence on whether different MBCT delivery formats can broaden access to individuals across the clinical trajectory of recurrent depression while preserving clinical benefit and good value for money in routine services. The trial will also assess outcomes from both healthcare and societal perspectives, which is important given the significant indirect costs of recurrent depression in Spain, including work disability and reduced productivity. As digitally supported care becomes more common, rigorous evaluation of its clinical and economic impact is essential to ensure that digital delivery improves outcomes and delivers measurable public health value.
Interventions
BEHAVIORALGroup Mindfulness-Based Cognitive Therapy
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.
BEHAVIORALMindfulness-Based Cognitive Therapy Self-Help
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.
OTHERTreatment as Usual (TAU)
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.
Sponsors
Fundació Sant Joan de Déu
Carlos III Health Institute
Obra Social La Caixa, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months | 6- and 12-month follow-ups | The primary outcome will be transitions between clinically defined states of recurrent depression over the 12-month follow-up, assessed in a time-to-event analysis. 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GRID-HAMD | Baseline, post-treatment, and 6- and 12-month follow-ups | Depressive symptoms |
| Patient Health Questionnaire (PHQ-9) | Baseline | Depressive symptoms |
| Positive and Negative Affect Schedule (PANAS) | Baseline, post-treatment, and 6- and 12-month follow-ups | Negative Affect |
| Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) | Baseline, post-treatment, and 6- and 12-month follow-ups | Mental well-being |
| EuroQoL-5D (EQ-5D-5L) | Baseline, post-treatment, and 6- and 12-month follow-ups | Health-related quality of life |
| Client Service Receipt Inventory (CSRI) | Baseline, 12-month follow-ups | Use of health and social services |
| Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) | Baseline, post-treatment, 6- and 12-month follow-ups | Depressive symptom severity Score range is 0-27, lower scores indicating lower depressive symptom severity. |
Countries
Spain
Contacts
CONTACTJesus Montero, PhD
CONTACTJaime Navarrete, PhD
PRINCIPAL_INVESTIGATORJesus Montero, PhD
Fundació Sant Joan de Déu
Outcome results
None listed