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

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.

NCT Number	NCT07235852
Lead Sponsor	Khyber Medical University Peshawar Collaborators: Keele University, Hayatabad Medical Complex
Conditions	HIV Infections, Depression, Anxiety Disorders
Enrollment	50 participants
Start Date	2025-09-15
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-05-25 (estimated)
Updated on ClinicalTrials.gov	2026-06-26