Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT06832605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bounce-Back From Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sociodemographic-clinical data', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Socio-demographic data will include self-reported sex, date of birth (age), ethnicity, marital status, number of children, cohabitation, employment status and satisfaction, economic situation and relevant negative life events in the previous 6 months.\n\nClinical data include history of mental illness, vulnerability factors (number of previous major depressive episodes, age at first onset of depression, presence of previous severe, prolonged or resistant episodes, childhood adversity (Childhood Trauma Questionnaire-Short Form \\[CTQ-SF\\]), number of hospital admissions, number of suicide attempts (if any), family history of mental illness and suicide, previous psychiatric and/or psychological treatments, life disorganisation (e.g., inability to work), type and dosage of medication at baseline (if prescribed), and psychological treatments received (during the last year), inability to work), type and dosage of medication at baseline (if prescribed), and psychological treatments received'}, {'measure': 'Brooding subscale of Ruminative Responses Scale-Short Form (RRS)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Rumination'}, {'measure': 'Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Mindfulness skills'}, {'measure': 'Decentering subscale of Experiences Questionnaire (EQ)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Decentring'}, {'measure': 'Sussex-Oxford Compassion Scale (SOCS-S)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Self-compassion'}, {'measure': 'Ecological Momentary Assessment (EMA)', 'timeFrame': 'Daily for 8 weeks', 'description': 'The m-Path platform will be used and once a day during the 8 weeks of treatment we will assess mood states.'}, {'measure': 'Mindfulness-Based Interventions-Participants; Assessment of Teaching (MBI:PAT)', 'timeFrame': 'Up to 8 weeks', 'description': 'Participants´ perspective on the competence of MBCT education'}, {'measure': 'Mindfulness-Based Interventions Teaching Assessment Criteria (MBI-TAC)', 'timeFrame': 'Up to 8 weeks', 'description': 'Participants´ perspective on the competence of MBCT education'}], 'primaryOutcomes': [{'measure': 'Time from randomisation to relapse or recurrence of major depression at 12-month follow-up', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale (HDRS)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Depressive symptoms'}, {'measure': 'Beck Depression Inventory II (BDI-II)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Severity of depression'}, {'measure': 'Positive and Negative Affect Schedule (PANAS)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Positive and Negative Affect'}, {'measure': 'Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Mental well-being'}, {'measure': 'EuroQoL-5D (EQ-5D-5L)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Health-related quality of life'}, {'measure': 'Client Service Receipt Inventory (CSRI)', 'timeFrame': 'Through study completion, an average of 1 year after randomization', 'description': 'Use of health and social services'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'MBCT', 'Relapse/recurrence prevention', 'Cost-utility', 'RCT'], 'conditions': ['Depression - Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Objectives: To analyse the effectiveness of adding: (i) mindfulness-based cognitive therapy (MBCT) delivered through 8 videoconference group sessions (group MBCT), and (ii) MBCT delivered through a self-help manual and 3 low-intensity group support sessions (beginning, middle, and end of the program) via videoconference (supported MBCT self-help) to treatment as usual (TAU, normally maintenance antidepressant medication), for the treatment of patients with recurrent depression, compared with TAU alone. Furthermore, we will assess the cost-utility of group MBCT vs. supported MBCT self-help vs. TAU alone, identifying potential predictors and moderators of response, and exploring the mechanisms through which the interventions exert effects.\n\nStudy 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), and Hospital del Mar (Barcelona).\n\nParticipants: Adult patients (n=300) with recurrent depression and high risk of relapse will be randomly assigned to group MBCT, supported MBCT self-help, or TAU.\n\nPrimary outcome: time from randomisation to depressive relapse/recurrence at 12-month follow-up (DSM-5). Secondaries: residual symptoms, well-being, quality of life, costs, and quality-adjusted life years. Process measures: rumination, mindfulness, decentering, affectivity, and self-compassion.\n\nMain statistical analyses: Hazard ratios will be calculated using survival analysis. Secondary outcomes, predictors, and moderators will be tested using regression-based approaches. Incremental cost-utility ratios and mediation path-analyses will be estimated. Acceptability will be evaluated using qualitative methods.', 'detailedDescription': 'Depression is a prevalent mental health disorder, affecting around 10% of the Spanish population at least once in their lifetime. It is a recurrent condition with significant personal and societal costs. Despite available treatments, more than half of those affected experience multiple relapses, with higher risks after each episode. In Spain, antidepressants are commonly used for relapse prevention, but many patients prefer psychological treatments due to the side effects and low adherence associated with medication.\n\nMindfulness-Based Cognitive Therapy (MBCT) is a psychological intervention designed to prevent depressive relapse. It involves weekly two-hour sessions over two months. In other countries, particularly in the English-speaking world, MBCT has been shown to reduce relapse risk by 25%, making it a promising alternative or complement to long-term antidepressant use. MBCT helps patients recognize early signs of depression and manage negative thoughts, preventing the onset of new episodes. It has gained recognition in countries like the UK, where it is recommended for recurrent depression in public healthcare systems.\n\nHowever, the effectiveness of MBCT for relapse prevention has not yet been fully evaluated in Spain through randomized clinical trials. This project aims to determine whether MBCT, added to usual treatment (TAU), is more effective than TAU alone in preventing depressive relapse or recurrence in Spanish adults with recurrent depression. The study will evaluate both in-person group MBCT sessions via videoconference and self-help formats, exploring their cost-utility, psychological mechanisms, and patient characteristics to identify those most likely to benefit from the therapy.\n\nThe Bounce-Back from Depression multicentre project will shed light on the application of MBCT in the Spanish context for the prevention of depressive relapse/recurrence. The use of different delivery formats will provide information about effectiveness, scalability, and cost-benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18.\n* Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD), in partial remission.\n* Internet access (via smartphone and computer).\n* Understanding of written and read Spanish language.\n\nExclusion Criteria:\n\n* Current severe MDD, current/past psychosis, bipolar disorder, history of schizophrenia, schizoaffective disorder, organic mental disorder, current severe substance abuse, organic brain damage, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical treatment or therapy.\n* No experience in the use of new technologies (computers/smartphones).\n* Previously completed mindfulness training or extensive experience in meditation (i.e., i.e., no experience in the use of new technologies).\n* Concurrent psychotherapy.\n* No experience in the use of new technologies (computers/smart phones).\n* Previously completed mindfulness training or extensive meditation experience (i.e. courses, retreats, or regular meditation).'}, 'identificationModule': {'nctId': 'NCT06832605', 'acronym': 'BECOME', 'briefTitle': 'Bounce-Back From Depression', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Sant Joan de Déu'}, 'officialTitle': 'Effectiveness and Cost-utility of Mindfulness-based Cognitive Therapy (MBCT) to Prevent Depressive Relapse or Recurrence in Spanish Adults With Recurrent Depressive Disorder: a Controlled Trial.', 'orgStudyIdInfo': {'id': 'PI23/00021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual (TAU)', 'description': 'TAU is administered in current daily practice and is defined as instructing participants to consult their family doctor or usual healthcare professional, as they normally would, if they experience symptomatic deterioration or difficulties during the study.', 'interventionNames': ['Other: Treatment as Usual (TAU)']}, {'type': 'EXPERIMENTAL', 'label': 'MBCT self-help', 'description': "The 'MBCT self-help' is based on the book 'The Mindfulness Way: An 8-week plan to free yourself from depression and emotional stress'. The book presents the 8-week MBCT course as a self-help booklet. Participants are asked to guide themselves using the self-help book. The book provides elaborate and practical mindfulness guidelines that can be exercised each week, as well as questions to help with reflection, ways to check progress and valuable feedback from others who have undertaken this MBCT programme.", 'interventionNames': ['Behavioral: MBCT self-help']}, {'type': 'EXPERIMENTAL', 'label': 'Group MBCT', 'description': 'Group MBCT\' will follow the treatment manual "Mindfulness-Based Cognitive Therapy for Depression". Group MBCT\' is a systematic training in mindfulness meditation techniques to teach participants skills to prevent relapse/recurrence of depression. Treatment includes weekly 2-hour classes over an 8-week period with home exercises, a full day of practice (6 hours long, adapted for online delivery), and 4 booster sessions offered every 3 months from the start of the programme.', 'interventionNames': ['Behavioral: MBCT group']}], 'interventions': [{'name': 'MBCT group', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Based Cognitive Therapy', 'Treatment as Usual (TAU)'], 'description': 'MBCT is a systematic training in mindfulness meditation techniques to teach participants skills to prevent relapse/recurrence of depression. Treatment includes weekly 2-hour classes over an 8-week period with home exercises, a full day of practice (6 hours long, adapted for online delivery), and 4 booster sessions offered every 3 months from the start of the programme.\n\nStandard pharmacological treatment usually provided to patients suffering depression.', 'armGroupLabels': ['Group MBCT']}, {'name': 'MBCT self-help', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Based Cognitive Therapy', 'Treatment as Usual (TAU)'], 'description': "The 'MBCT self-help' is based on the book 'The Mindfulness Way: An 8-week plan to free yourself from depression and emotional stress'. The book presents the 8-week MBCT course as a self-help booklet. Participants are asked to guide themselves using the self-help book. The book provides elaborate and practical mindfulness guidelines that can be exercised each week, as well as questions to help with reflection, ways to check progress and valuable feedback from others who have undertaken this MBCT programme.\n\nStandard pharmacological treatment usually provided to patients suffering depression.", 'armGroupLabels': ['MBCT self-help']}, {'name': 'Treatment as Usual (TAU)', 'type': 'OTHER', 'description': 'Standard pharmacological treatment usually provided to patients suffering depression.', 'armGroupLabels': ['Treatment as Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08830', 'city': 'Sant Boi de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc Sanitari Sant Joan de Déu (PSSJD)', 'geoPoint': {'lat': 41.34357, 'lon': 2.03659}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Jesus Montero, PhD', 'role': 'CONTACT', 'email': 'jesus.montero@sjd.es', 'phone': '(34) 936 615 208 - 12733'}, {'name': 'Jaime Navarrete, PhD', 'role': 'CONTACT', 'email': 'jaime.navarrete@sjd.es', 'phone': '(34) 936 615 208 - 12734'}], 'overallOfficials': [{'name': 'Jesus Montero, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundació Sant Joan de Déu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Sant Joan de Déu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher Miguel Servet (CP21/00080)', 'investigatorFullName': 'Jesus Montero Marin', 'investigatorAffiliation': 'Fundació Sant Joan de Déu'}}}}