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

November 20, 2025 updated by: Swiss Medical Academy Maroc

INNOV5-MH-MAROC: Multicenter Pragmatic Randomized Controlled Trial Evaluating an Integrated Program of Five WHO Innovations in Mental Health in Morocco

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Sion, Switzerland, 1950
        • Swiss Medical Academy Maroc
        • Contact:
        • Contact:
          • 0764429310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms (PHQ-9)
Time Frame: Baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety symptoms (GAD-7)
Time Frame: Baseline to 6 months
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.
Baseline to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life (WHOQOL-BREF)
Time Frame: Baseline to 6 months
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+).
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Medical Academy Maroc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2028

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-INNOV5-MH-MAROC-01 (Other Identifier: Swiss Medical Academy Maroc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

From 12 months after publication of the primary trial results and for up to 5 years thereafter.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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