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

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.

Conditions

• HIV Infections
• Depression
• Anxiety Disorders

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.

Sponsors & Collaborators

• Keele University

  collaborator OTHER

• Hayatabad Medical Complex

  collaborator OTHER_GOV

• Khyber Medical University Peshawar

  lead OTHER

Principal Investigators

• Huma Mughal, MPH,PhD* · Keele University

• Prof Monica Magadi, PhD · Keele University

• Dr James Prior, PhD · Keele University

• Prof Saeed Farooq, PhD · Keele University

• Dr Shaista Rasool, PhD · Khyber Medical University

• Dr Mirat Gul, PhD · Mayo Hospital Lahore

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2026-03-31

Completion

2026-05-25

Countries

• Pakistan

Study Locations