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

NCT07258095 | Not Yet Recruiting DMC

• 1 other identifier: SMA-INNOV5-MH-MAROC-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Keywords

Depression; Anxiety; Adolescent mental health; Primary care; School-based mental health; Digital mental health; Virtual reality exposure; mhGAP; Task-shifting; Morocco

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms (PHQ-9)

  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.

  Baseline to 6 months

Secondary Outcomes (1)

• Change in anxiety symptoms (GAD-7)

  Baseline to 6 months

Other Outcomes (1)

• Change in quality of life (WHOQOL-BREF)

  Baseline to 6 months

Study Arms (2)

INNOV5 Integrated Program

EXPERIMENTAL

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.

Behavioral: INNOV5 Integrated Mental Health Program; Behavioral: Enhanced Treatment as Usual (TAU+)

Enhanced Treatment as Usual (TAU+)

ACTIVE COMPARATOR

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.

Behavioral: INNOV5 Integrated Mental Health Program; Behavioral: Enhanced Treatment as Usual (TAU+)

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+); INNOV5 Integrated Program

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.

Enhanced Treatment as Usual (TAU+); INNOV5 Integrated Program

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Medical Academy Maroc: lead

Study Sites (1)

Swiss Medical Academy Maroc

Sion, 1950, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders; Mental Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Younes MOUDAR, MPH

CONTACT

+41764429310; y.moudar@ardevaz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): March 1, 2028
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 12 months after publication of the primary trial results and for up to 5 years thereafter.
• Access Criteria: Researchers must submit a brief research proposal and analysis plan to the Swiss Medical Academy data access committee (contact@swissmedicalacademy.ma ). 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.

Locations

CH (1)