Clinical Trial

INNOV5-MH-MAROC: Integrated Mental Health Care for Adolescents and Adults in Primary Care Centers and Schools in Morocco

Study acronym: INNOV5-MH
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07258095
Lead Sponsor Swiss Medical Academy Maroc
Conditions Depression in Adolescence, Depression in Adults, Anxiety, Mental and Behavioural Disorders
Enrollment 146 participants
Start Date 2028-03-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-02