NCT06442007

Universally Delivered Interventions for Young People

A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 564 (estimated)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: Accepted

Summary

Mental health problems are amongst the major contributors to disease burden globally. According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China. Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available. One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology. This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.

Detailed description

A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan. Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions. Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar. All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.

Conditions

• Distress, Emotional

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Activation - single session intervention (BA-SSI)	Single session intervention
BEHAVIORAL	4-session Mindset intervention	This is comprised of 4 sessions.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-10-30
• Completion: 2025-12-30
• First posted: 2024-06-04
• Last updated: 2024-12-10

Locations

1 site across 1 country: Pakistan