Clinical Trial

Evaluating the Effectiveness of a School-based Stepped Care Treatment Model for Adolescent Depression in Pakistan

Study acronym: SMART-STEP
Active, Not Recruiting
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Summary
This study aims to test the effectiveness of a stepped-care model to reduce depressive symptoms in adolescents in school settings in Pakistan. The study will examine whether the universal intervention, delivered by non-specialists, can reduce depressive symptoms in adolescents after 3 months. For adolescents who do not improve with universal intervention, the study will assess whether a Cognitive Behavioural Therapy (CBT)-based guided self-help app can provide additional support as a second-step intervention. Six hundred adolescents aged 13-15 from 40 schools in Rawalpindi, Pakistan, will take part. The study will determine which interventions work best and for which students to reduce depressive symptoms in school settings in Pakistan.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2025-12-01 -> 2026-10-01 2026-05-06
minor Completion pushed: 2025-12-01 -> 2026-10-01 2026-05-06
Trial Details
NCT Number NCT07399314
Lead Sponsor Global Institute of Human Development
Collaborators: National Ministry of Health Services, Regulations and Coordination, Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi, Shifa Tameer-e-Millat University
Conditions Depression Anxiety Disorder, Psychological Distress, Well-Being, Psychological
Enrollment 600 participants
Start Date 2025-11-13
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-05