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

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.

Conditions

• Depression Anxiety Disorder
• Psychological Distress
• Well-Being, Psychological

Interventions

BEHAVIORAL

Universal Intervention & CBT-based Guided Self-Help Application

The first-stage intervention is universal intervention in the intervention arm and TAU in the control arm. In the intervention arm, adolescents receive universal intervention from non-specialists, while in the control arm, they receive TAU. Universal intervention, based on developmental, behavioral, social, and cognitive theories, aims to provide basic psychological support to adolescents, build their socioemotional life skills, and strengthen collaboration between parents and schools, including referral pathways for those requiring specialist care. The second-stage intervention is a CBT-based self-help app. At 3-months, adolescents scoring ≥5 on the PHQ-9 in both arms (indicating the presence of depressive symptoms) are individually re-randomized to continue their initial treatment (universal or TAU) or receive a step-up, CBT-based guided self-help app.

Sponsors & Collaborators

• National Ministry of Health Services, Regulations and Coordination

  collaborator UNKNOWN

• Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi

  collaborator UNKNOWN

• Shifa Tameer-e-Millat University

  collaborator OTHER

• Global Institute of Human Development

  lead OTHER

Principal Investigators

• Syed Usman Hamdani, PhD MBBS · Global Institute of Human Development

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

13 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-13

Primary Completion

2026-10-01

Completion

2026-10-01

Countries

• Pakistan

Study Locations