Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-29 @ 2:46 PM
Study NCT ID:
NCT07258095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INNOV5-MH-MAROC: Integrated Mental Health Care for Adolescents and Adults in Primary Care Centers and Schools in Morocco
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized 1:1 to either the INNOV5 integrated mental health program or enhanced treatment as usual (TAU+) in a two-arm parallel-group pragmatic trial conducted in Moroccan primary care centers and high schools.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in quality of life (WHOQOL-BREF)', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in health-related quality of life measured by the WHOQOL-BREF. The WHOQOL-BREF is a 26-item self-report questionnaire assessing four domains (physical health, psychological health, social relationships and environment). Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. Mean change in WHOQOL-BREF domain scores from baseline to 6 months will be compared between participants allocated to the INNOV5 integrated mental health program and those allocated to enhanced treatment as usual (TAU+).'}], 'primaryOutcomes': [{'measure': 'Change in depressive symptoms (PHQ-9)', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to 6 months comparing INNOV5 versus enhanced treatment as usual (TAU+). The PHQ-9 is a 9-item self-report scale of depressive symptoms; total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety symptoms (GAD-7)', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in Generalized Anxiety Disorder-7 (GAD-7) total score from baseline to 6 months between participants allocated to the INNOV5 integrated mental health program and those allocated to enhanced treatment as usual (TAU+). The GAD-7 is a 7-item self-report measure of anxiety symptoms; total scores range from 0 to 21, with higher scores indicating more severe anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Anxiety', 'Adolescent mental health', 'Primary care', 'School-based mental health', 'Digital mental health', 'Virtual reality exposure', 'mhGAP', 'Task-shifting', 'Morocco'], 'conditions': ['Depression in Adolescence', 'Depression in Adults', 'Anxiety', 'Mental and Behavioural Disorders']}, 'descriptionModule': {'briefSummary': 'Depression and anxiety are highly prevalent among adolescents and adults in Morocco, while access to evidence-based care in primary care centers and schools remains limited. This multicenter pragmatic randomized controlled trial evaluates an integrated mental health program inspired by WHO priorities. The INNOV5 intervention combines: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions; (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools. The primary objective is to compare the change in depressive symptoms (PHQ-9) at 6 months between INNOV5 and enhanced treatment as usual (TAU+). Secondary objectives include effects on anxiety (GAD-7), quality of life (WHOQOL-BREF), suicidal ideation and behavior (C-SSRS), functioning, school attendance, and feasibility and acceptability of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents (12-17 years) and adults (≥18 years) attending participating primary care centres or high schools in Morocco.\n* Clinically significant depressive and/or anxiety symptoms identified by screening (PHQ-9 and/or GAD-7) according to study thresholds.\n* Able to understand study procedures and provide informed consent (or parental consent and adolescent assent for minors).\n* Planning to remain in the study area for at least 12 months.\n\nExclusion Criteria:\n\n* Acute psychiatric emergency requiring immediate specialised care (e.g. psychosis, high-risk suicidal crisis, severe substance use disorder).\n* Cognitive impairment or severe medical condition preventing participation in the intervention or assessments.\n* Current participation in another interventional mental health trial.\n* Any other situation judged by the investigator to make participation unsafe or inappropriate.'}, 'identificationModule': {'nctId': 'NCT07258095', 'acronym': 'INNOV5-MH', 'briefTitle': 'INNOV5-MH-MAROC: Integrated Mental Health Care for Adolescents and Adults in Primary Care Centers and Schools in Morocco', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Medical Academy Maroc'}, 'officialTitle': 'INNOV5-MH-MAROC: Multicenter Pragmatic Randomized Controlled Trial Evaluating an Integrated Program of Five WHO Innovations in Mental Health in Morocco', 'orgStudyIdInfo': {'id': 'SMA-INNOV5-MH-MAROC-01'}, 'secondaryIdInfos': [{'id': 'SMA-INNOV5-MH-MAROC-01', 'type': 'OTHER', 'domain': 'Swiss Medical Academy Maroc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INNOV5 Integrated Program', 'description': 'Participants receive the INNOV5 integrated mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools.', 'interventionNames': ['Behavioral: INNOV5 Integrated Mental Health Program', 'Behavioral: Enhanced Treatment as Usual (TAU+)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Treatment as Usual (TAU+)', 'description': 'Participants receive enhanced treatment as usual in participating primary care centers and schools. TAU+ consists of routine mental health care and referrals available at each site, plus minimal enhancements such as access to WHO mhGAP materials and basic information and referral resources. Participants do not receive the specific INNOV5 program components.', 'interventionNames': ['Behavioral: INNOV5 Integrated Mental Health Program', 'Behavioral: Enhanced Treatment as Usual (TAU+)']}], 'interventions': [{'name': 'INNOV5 Integrated Mental Health Program', 'type': 'BEHAVIORAL', 'description': 'Integrated multicomponent mental health program combining: (1) a collaborative care model in primary care; (2) mhGAP-based task-shifting and stepped care; (3) validated digital mental health interventions (apps and online tools); (4) virtual reality exposure therapy for selected anxiety- or trauma-related cases; and (5) a school-based mental health promotion component in participating high schools.', 'armGroupLabels': ['Enhanced Treatment as Usual (TAU+)', 'INNOV5 Integrated Program']}, {'name': 'Enhanced Treatment as Usual (TAU+)', 'type': 'BEHAVIORAL', 'description': 'Usual mental health care and referrals available at participating primary care centers and schools, with minimal enhancements such as WHO mhGAP materials and basic information and referral resources, but without access to the INNOV5 integrated program components.', 'armGroupLabels': ['Enhanced Treatment as Usual (TAU+)', 'INNOV5 Integrated Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1950', 'city': 'Sion', 'country': 'Switzerland', 'contacts': [{'name': 'Younes Moudar, MPH', 'role': 'CONTACT', 'email': 'y.moudar@ardevaz.com', 'phone': '+41764429310'}, {'name': '0764429310', 'role': 'CONTACT'}], 'facility': 'Swiss Medical Academy Maroc', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}], 'centralContacts': [{'name': 'Younes MOUDAR, MPH', 'role': 'CONTACT', 'email': 'y.moudar@ardevaz.com', 'phone': '+41764429310'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From 12 months after publication of the primary trial results and for up to 5 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be made available to qualified researchers upon reasonable request, after completion of the trial and publication of the main results. Data sharing will comply with Moroccan data protection law (Loi 09-08), CNDP authorization and institutional policies. A data sharing agreement will be required.', 'accessCriteria': 'Researchers must submit a brief research proposal and analysis plan to the Swiss Medical Academy data access committee (contact@swissmedicalacademy.ma\n\n). Requests will be reviewed for scientific merit, ethical approval and compliance with data protection regulations. Upon approval and signature of a data sharing agreement, de-identified IPD will be transferred via a secure data sharing platform.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Medical Academy Maroc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}