Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
Khyber Medical University Peshawar
50 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Adults aged 18-65 years.
- Pakistani nationals and residents.
- Confirmed HIV diagnosis (newly diagnosed or on ART within 1 month of diagnosis, or already on lifelong ART, according to UNAIDS HIV diagnostic standards).
- Meeting criteria for depression and anxiety: HADS subscale score \>8 on both depression and anxiety, and total HADS score \>15.
- HIV patients with comorbid conditions (e.g., Hepatitis, HCV) may be included if HIV is the primary condition.
Exclusion Criteria6
- Diagnosis of bipolar disorder, psychosis, or other severe mental illness according to ICD-11 or DSM-5-TR.
- Evidence of learning disability or severe substance use disorder (except nicotine).
- Currently receiving psychotherapy or antidepressant medication within the last 6 months.
- Current suicidality (per WHO mhGAP) or suicide attempt within the last 2 years.
- HIV-associated neurocognitive disorders (HAND) or severe complications of HIV preventing participation, as judged by treating physician.
- Living in the same household as another study participant (to prevent contamination between arms).
Interventions
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.
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)
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NCT07235852