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

NCT ID: NCT07258095

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-03-01
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

INNOV5 Integrated Mental Health Program

Intervention Type: 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+)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

INNOV5 Integrated Mental Health Program

Intervention Type: 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+)

Intervention Type: 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.

Interventions

INNOV5 Integrated Mental Health Program

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.

Intervention Type: BEHAVIORAL

Enhanced Treatment as Usual (TAU+)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescents (12-17 years) and adults (≥18 years) attending participating primary care centres or high schools in Morocco.
• Clinically significant depressive and/or anxiety symptoms identified by screening (PHQ-9 and/or GAD-7) according to study thresholds.
• Able to understand study procedures and provide informed consent (or parental consent and adolescent assent for minors).
• Planning to remain in the study area for at least 12 months.

Exclusion Criteria

• Acute psychiatric emergency requiring immediate specialised care (e.g. psychosis, high-risk suicidal crisis, severe substance use disorder).
• Cognitive impairment or severe medical condition preventing participation in the intervention or assessments.
• Current participation in another interventional mental health trial.
• Any other situation judged by the investigator to make participation unsafe or inappropriate.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Medical Academy Maroc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Swiss Medical Academy Maroc

Sion, , Switzerland

Countries

Switzerland

Central Contacts

Younes MOUDAR, MPH

Role: CONTACT

y.moudar@ardevaz.com

+41764429310

Facility Contacts

Younes Moudar, MPH

Role: primary

y.moudar@ardevaz.com

+41764429310

0764429310

Role: backup

Other Identifiers

SMA-INNOV5-MH-MAROC-01

Identifier Type: -

Identifier Source: org_study_id

SMA-INNOV5-MH-MAROC-01

Identifier Type: OTHER

Identifier Source: secondary_id