RecruitingNot ApplicableNCT07235852

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

Sponsor

Khyber Medical University Peshawar

Enrollment

50 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Depression HIV Infections Anxiety Disorders

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a cognitive behavioral therapy (CBT) program — a structured talking therapy that helps change negative thought patterns — can reduce depression and anxiety in people in Pakistan who are living with HIV. **You may be eligible if...** - You are between 18 and 65 years old - You are a Pakistani national or resident - You have a confirmed HIV diagnosis - You are experiencing both depression and anxiety (above a certain score on a standard questionnaire) **You may NOT be eligible if...** - You have been diagnosed with bipolar disorder, psychosis, or another serious mental illness - You have a learning disability or severe substance use disorder (other than nicotine) - You are currently receiving psychotherapy or antidepressant medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCulturally 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.

OTHERTreatment 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.