Effectiveness and Cost-Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference in the Spanish National Health System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 342
- 试验地点
- 11
- 主要终点
- Time from randomisation to relapse or recurrence of major depression at 12-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Treatment as Usual (TAU)
TAU will be delivered as it is in routine clinical practice.
干预措施: Treatment as Usual (TAU) (Other)
Supported Mindfulness-Based Cognitive Therapy Self-Help
Patients will continue receiving TAU at the same time.
干预措施: Mindfulness-Based Cognitive Therapy Self-Help (Behavioral)
Group Mindfulness-Based Cognitive Therapy
Patients will continue receiving TAU at the same time.
干预措施: Group Mindfulness-Based Cognitive Therapy (Behavioral)
结局指标
主要结局
Time from randomisation to relapse or recurrence of major depression at 12-month follow-up
时间窗: Through study completion, an average of 1 year after randomization
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.
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months
时间窗: 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.
次要结局
- Hamilton Depression Rating Scale (HDRS)(Through study completion, an average of 1 year after randomization)
- Beck Depression Inventory II (BDI-II)(Through study completion, an average of 1 year after randomization)
- Positive and Negative Affect Schedule (PANAS)(Through study completion, an average of 1 year after randomization)
- Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)(Through study completion, an average of 1 year after randomization)
- EuroQoL-5D (EQ-5D-5L)(Through study completion, an average of 1 year after randomization)
- Client Service Receipt Inventory (CSRI)(Through study completion, an average of 1 year after randomization)
- GRID-HAMD(Baseline, post-treatment, and 6- and 12-month follow-ups)
- Patient Health Questionnaire (PHQ-9)(Baseline)
- Positive and Negative Affect Schedule (PANAS)(Baseline, post-treatment, and 6- and 12-month follow-ups)
- Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)(Baseline, post-treatment, and 6- and 12-month follow-ups)
- EuroQoL-5D (EQ-5D-5L)(Baseline, post-treatment, and 6- and 12-month follow-ups)
- Client Service Receipt Inventory (CSRI)(Baseline, 12-month follow-ups)
- Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16)(Baseline, post-treatment, 6- and 12-month follow-ups)
研究者
Jesus Montero Marin
Senior Researcher Miguel Servet (CP21/00080)
Fundació Sant Joan de Déu