Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 2:55 PM
Study NCT ID:
NCT06990035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MADR Scale for Depression', 'timeFrame': 'Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).', 'description': 'The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome.'}, {'measure': 'Beck Depression Inventory - II', 'timeFrame': 'Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).', 'description': 'The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.'}, {'measure': 'Zung Self-Rating Depression Scale', 'timeFrame': 'Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).', 'description': 'The Zung Self-Rating Depression Scale (ZRS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression'}, {'measure': 'Personal and Social Performance Scale', 'timeFrame': 'Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).', 'description': 'The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome.'}, {'measure': 'World Health Organization Quality of Life - Bref', 'timeFrame': 'Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).', 'description': 'The WHOQOL-BREF is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.'}], 'secondaryOutcomes': [{'measure': 'Immunitary-related factors levels', 'timeFrame': 'Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).', 'description': 'Plasma/serum levels of cytokines'}, {'measure': 'Gut Microbiome Composition', 'timeFrame': 'Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major depressive disorder', 'Physical activity', 'Mediterranean Diet', 'Microbiome'], 'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.\n\nParticipants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).\n* Depressive symptoms assessed using MADR, BDI, or ZDR scales.\n* Ability to provide written informed consent.\n* Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.\n\nExclusion Criteria:\n\n* Patients with severe psychopathology.\n* Medical contraindications to physical activity.\n* Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.\n* Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months\n* Active gastrointestinal diseases\n* Autoimmune and/or chronic inflammatory disorders'}, 'identificationModule': {'nctId': 'NCT06990035', 'briefTitle': 'Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Centro San Giovanni di Dio Fatebenefratelli'}, 'officialTitle': 'Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato', 'orgStudyIdInfo': {'id': '5M-2022-23685026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Mediterranean diet lessons program', 'interventionNames': ['Behavioral: Mediterranean diet lessons program']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Physical activity program', 'interventionNames': ['Behavioral: Mediterranean diet lessons program', 'Behavioral: Physical activity']}], 'interventions': [{'name': 'Mediterranean diet lessons program', 'type': 'BEHAVIORAL', 'description': 'Participants will attend five one-hour lessons delivered by qualified professionals to learn about foods that have a positive impact on cognitive function and how to incorporate them into their dietary regimen.', 'armGroupLabels': ['Control Group', 'Experimental Group']}, {'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': 'Participants will undergo a 12-week physical exercise program guided by specified personal trainers.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25125', 'city': 'Brescia', 'country': 'Italy', 'contacts': [{'name': 'Annamaria Cattaneo, PhD', 'role': 'CONTACT', 'email': 'acattaneo@fatebenefratelli.eu', 'phone': '030 3501599'}], 'facility': 'IRCCS Centro San Giovanni fi Dio Fatebenefratelli', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'centralContacts': [{'name': 'Annamaria Cattaneo, PhD', 'role': 'CONTACT', 'email': 'acattaneo@fatebenefratelli.eu', 'phone': '0039 030 3501599'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Centro San Giovanni di Dio Fatebenefratelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}