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.
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.
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.
Parallel
INNOV5 Integrated Mental Health Program
BehavioralIntegrated 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+)
BehavioralUsual 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.
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.
Change in anxiety symptoms (GAD-7)
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.
Change in quality of life (WHOQOL-BREF)
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+).
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