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RECRUITING
NCT07235852
NA

Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention

Sponsor: Khyber Medical University Peshawar

View on ClinicalTrials.gov

Summary

This pilot feasibility randomized controlled trial will test a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention for depression and anxiety among people living with HIV (PLHIV) in Peshawar, Pakistan. Fifty participants will be randomized to either receive six sessions of the adapted CBT delivered by trained HIV health workers or treatment as usual (TAU). The study will assess feasibility, acceptability, recruitment and retention rates, and preliminary clinical outcomes, to inform the development of a larger definitive trial.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-09-15

Completion Date

2026-05-25

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

BEHAVIORAL

Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)

A six-session culturally adapted cognitive behavioral therapy (Ca-CBT) intervention designed for people living with HIV (PLHIV) with depression or anxiety. Sessions will last 45-60 minutes each, delivered weekly by trained HIV health workers under professional supervision. The intervention incorporates culturally relevant stories, metaphors, and self-help audio/video materials, tailored for low-literacy populations. The therapy focuses on reducing depression and anxiety, improving functioning, enhancing adherence to antiretroviral therapy (ART), and problem-solving skills.

OTHER

Treatment as Usual (TAU)

Participants will receive routine HIV care as provided at Family Care Centres under the National HIV Control Program. This includes free initiation and continuation of antiretroviral therapy (ART), adherence counselling, regular health check-ups, and medication refills. No additional psychological therapy or behavioral intervention will be provided.

Locations (1)

Family Care Centre (FCC), Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan