NCT07235852

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Khyber Medical University Peshawar · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This feasibility pilot trial aims to evaluate the acceptability and feasibility of a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention for PLHIV with comorbid depression or anxiety in Pakistan. The study will be conducted at the Family Care Centre (FCC), Hayatabad Medical Complex, Peshawar, which provides HIV diagnosis, registration, treatment, and adherence counselling. Fifty eligible participants aged 18-65, living with HIV, and meeting the Hospital Anxiety and Depression Scale (HADS) thresholds will be randomized (1:1) to intervention or treatment as usual. The intervention group will receive six consecutive sessions of Ca-CBT, designed to improve depression, anxiety, adherence to ART, and functionality. Sessions will use culturally relevant materials, metaphors, and self-help tools, tailored for low-literacy populations. Delivery will be by HIV health workers trained and supervised under a cascade model. Primary feasibility outcomes include recruitment, retention, completion of therapy sessions, fidelity of delivery, and acceptability. Secondary outcomes include changes in depression (HADS), functioning (WHODAS), internalized stigma, ART adherence self-efficacy, health-related quality of life (EQ-5D), and trauma symptoms. Assessments will occur at baseline, 8 weeks (post-intervention), and 12 weeks (follow-up). The trial uses a randomized, single-blind (assessors) two-arm design. Recruitment will draw from the FCC registry of HIV patients. Sample size justification follows CONSORT guidelines for feasibility trials, with traffic-light progression criteria (stop/amend/go thresholds) for decision-making on a definitive trial. This study will provide essential data on feasibility, acceptability, and preliminary clinical signals to inform a full-scale RCT evaluating culturally adapted CBT for PLHIV in Pakistan.

Conditions

• HIV Infections
• Depression
• Anxiety Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-03-31
• Completion: 2026-05-25
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Pakistan