Major Depressive Disorder, Recurrent, in RemissionBECOMENCT06832605
Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference
A study testing Group Mindfulness-Based Cognitive Therapy, Mindfulness-Based Cognitive Therapy Self-Help and Treatment as Usual (TAU) in people with Major Depressive Disorder, Recurrent, in Remission and Major Depressive Disorder, Recurrent, Mild, run by Fundació Sant Joan de Déu at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild, Major Depressive Disorder, Recurrent, Moderate
- What is being tested?
- Group Mindfulness-Based Cognitive Therapy, Mindfulness-Based Cognitive Therapy Self-Help and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 5 sitesSpain
- Study dates
- 10 Jun 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Parc de Salut Mar
Barcelona, Barcelona, 08003
Matilde Elices, Doctor, melices@researchmar.net
- Recruiting
Fundacio Centre Higiene Mental Nou Barris
Barcelona, Barcelona
Giusi Rametti, Doctor, giusi.rametti@csm9b.com
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Jose M Rico, Doctor, rico_josgom@gva.es
- Recruiting
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, 08830
Jesus Montero, PhD, (+34) 936 615 208 ext. 12733, jesus.montero@sjd.es
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
Javier Prado, Doctor, jprado@salud.aragon.es
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild, Major Depressive Disorder, Recurrent, Moderate
- Being tested
- Group Mindfulness-Based Cognitive Therapy, Mindfulness-Based Cognitive Therapy Self-Help, Treatment as Usual (TAU)
- Keywords
- Depression, MBCT, Relapse/recurrence prevention, RCT, cost-effectiveness
- Medical subject headings
- Depressive Disorder, Major, Recurrence, Lymphoma, Follicular, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Mindfulness-Based Cognitive TherapyBehavioural
Also called Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)
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.
Mindfulness-Based Cognitive Therapy Self-HelpBehavioural
Also called Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | TAU will be delivered as it is in routine clinical practice. Receives: Other: Treatment as Usual (TAU) |
| Supported Mindfulness-Based Cognitive Therapy Self-Help | Active comparator | Patients will continue receiving TAU at the same time. Receives: Behavioral: Mindfulness-Based Cognitive Therapy Self-Help |
| Group Mindfulness-Based Cognitive Therapy | Experimental | Patients will continue receiving TAU at the same time. Receives: Behavioral: Group Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months
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.
Measured: 6- and 12-month follow-ups
Secondary outcomes (7)
GRID-HAMD
Depressive symptoms
Measured: Baseline, post-treatment, and 6- and 12-month follow-ups
Patient Health Questionnaire (PHQ-9)
Depressive symptoms
Measured: Baseline
Positive and Negative Affect Schedule (PANAS)
Negative Affect
Measured: Baseline, post-treatment, and 6- and 12-month follow-ups
Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)
Mental well-being
Measured: Baseline, post-treatment, and 6- and 12-month follow-ups
EuroQoL-5D (EQ-5D-5L)
Health-related quality of life
Measured: Baseline, post-treatment, and 6- and 12-month follow-ups
Client Service Receipt Inventory (CSRI)
Use of health and social services
Measured: Baseline, 12-month follow-ups
Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Depressive symptom severity Score range is 0-27, lower scores indicating lower depressive symptom severity.
Measured: Baseline, post-treatment, 6- and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start10 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Recurrent, in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, La Caixa Foundation
- Responsible party
- Principal investigator, Jesus Montero Marin, Fundació Sant Joan de Déu
- Investigators
- Jesus Montero, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832605
- Sponsor's protocol ID
- PI23/00021
- Acronym
- BECOME
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06832605
- Acronym / sponsor ID
- BECOME / PI23/00021
- Conditions
- Major Depressive Disorder, Recurrent, in Remission, Major Depressive Disorder, Recurrent, Mild, Major Depressive Disorder, Recurrent, Moderate
- Keywords
- Depression, MBCT, Relapse/recurrence prevention, RCT, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, La Caixa Foundation
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)TAU will be delivered as it is in routine clinical practice. |
| Supported Mindfulness-Based Cognitive Therapy Self-Help | Active comparator | Behavioral: Mindfulness-Based Cognitive Therapy Self-HelpPatients will continue receiving TAU at the same time. |
| Group Mindfulness-Based Cognitive Therapy | Experimental | Behavioral: Group Mindfulness-Based Cognitive TherapyPatients will continue receiving TAU at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Mindfulness-Based Cognitive TherapyAlso: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)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. | Behavioural | Group Mindfulness-Based Cognitive Therapy |
| Mindfulness-Based Cognitive Therapy Self-HelpAlso: Mindfulness Based Cognitive Therapy, Treatment as Usual (TAU)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. | Behavioural | Supported Mindfulness-Based Cognitive Therapy Self-Help |
| Treatment 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. | Other | Treatment as Usual (TAU) |
Primary outcome
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months
Time frame: 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.
7 secondary outcomes
GRID-HAMD
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
EuroQoL-5D (EQ-5D-5L)
Time frame: Baseline, post-treatment, and 6- and 12-month follow-ups
Client Service Receipt Inventory (CSRI)
Time frame: Baseline, 12-month follow-ups
Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Time frame: Baseline, post-treatment, 6- and 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesus Montero, PhD principal investigator
Fundació Sant Joan de Déu
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Mindfulness-Based Cognitive Therapy, Mindfulness-Based Cognitive Therapy Self-Help and Treatment as Usual (TAU) in people with Major Depressive Disorder, Recurrent, in Remission and Major Depressive Disorder, Recurrent, Mild, run by Fundació Sant Joan de Déu at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesus Montero, PhD ((34) 936 615 208 - 12733, jesus.montero@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition from remission to relapse/recurrence, analysed within a continuous-time multi-state model over 12 months (time frame: 6- and 12-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.