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

Study acronym: SMART-STEP
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 60 days later Oct 1, 2026 → Nov 30, 2026
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Record History

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  1. Primary and study completion pushed from Oct 1, 2026 to Nov 30, 2026 Show 5 more changesShow less
    • Interventions: Universal Intervention & CBT-based Guided Self-Help Application (Behavioral) to Universal Intervention & CBT-based Guided Self-Help Application (Behavioral)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 15 of 15 entries
    • Site details revised
    • Publications: details revised at 11 of 11 entries
  2. Primary and study completion pushed from Dec 1, 2025 to Oct 1, 2026
    • Trial status: Completed to Active, Not Recruiting
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Depression Anxiety Disorder, Psychological Distress, Well-Being, Psychological
Related terms Psychological Well-Being
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov