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Not yet recruiting NCT07258095

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

No phase Interventional Depression in Adolescence Depression in Adults Anxiety Mental and Behavioural Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INNOV5 Integrated Mental Health Program, Enhanced Treatment as Usual (TAU+).
Who it may be relevant to
Registry conditions: Depression in Adolescence, Depression in Adults, Anxiety, Mental and Behavioural Disorders. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in depressive symptoms (PHQ-9) [Time frame: Baseline to 6 months]
Secondary outcome measures (1)
  • Change in anxiety symptoms (GAD-7) [Time frame: Baseline to 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Swiss Medical Academy Maroc — Sion

Identifiers

NCT: NCT07258095 · SMA-INNOV5-MH-MAROC-01 · SMA-INNOV5-MH-MAROC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗