INNOV5-MH-MAROC: Multicenter Pragmatic Randomized Controlled Trial Evaluating an Integrated Program of Five WHO Innovations in Mental Health in Morocco
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms (PHQ-9)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in depressive symptoms (PHQ-9)
时间窗: 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.
次要结局
- Change in anxiety symptoms (GAD-7)(Baseline to 6 months)