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

Sponsor
Swiss Medical Academy Maroc
Study ID
NCT07258095
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression in Adolescence
  • Depression in Adults
  • Mental and Behavioural Disorders

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INNOV5 Integrated Mental Health Program — BEHAVIORAL
    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.
  • Enhanced Treatment as Usual (TAU+) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Dec 2, 2025
Start date
Mar 1, 2028
Status verified
Nov 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INNOV5 Integrated Program
    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.
  • Active Comparator: Enhanced Treatment as Usual (TAU+)
    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.

Primary Outcome Measure

Change in depressive symptoms (PHQ-9) [ Time Frame: Baseline to 6 months ]

Central Contacts

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