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

Swiss Medical Academy Maroc

Status: Begins enrollment in a year or more

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07258095

SMA-INNOV5-MH-MAROC-01 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

INNOV5 Integrated Program

Experimental group

Description:

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.

Treatment:

Behavioral: INNOV5 Integrated Mental Health Program

Behavioral: Enhanced Treatment as Usual (TAU+)

Enhanced Treatment as Usual (TAU+)

Active Comparator group

Description:

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.

Treatment:

Behavioral: INNOV5 Integrated Mental Health Program

Behavioral: Enhanced Treatment as Usual (TAU+)