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

Khyber Medical University Peshawar50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)BEHAVIORAL

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.

Treatment as Usual (TAU)OTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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).

Outcomes

Primary Outcomes

Feasibility of Recruitment - Enrollment Rate

The proportion of eligible participants who are successfully enrolled into the trial. This will be calculated as: (Number of participants enrolled / Number of eligible participants screened) \* 100%. Criteria: Proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%).

Time frame: Baseline to 12 weeks post-intervention.

Feasibility of Intervention - Retention in Therapy

The proportion of enrolled participants who complete at least 4 out of the 6 planned therapy sessions. This will be calculated as: (Number of participants completing ≥4 sessions / Total number of participants enrolled in the intervention arm) \* 100%. Criteria: proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%). Go: \>80%

Time frame: At the end of the 6-week intervention period

Feasibility of Data Collection - Follow-up Assessment Completion

The proportion of enrolled participants who complete the primary outcome assessments at the 12-week post-intervention time point. This will be calculated as: (Number of participants completing the 12-week assessment / Total number of participants enrolled) \* 100%. Criteria: proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%). Go: \>80%

Time frame: 12 weeks post-intervention

Secondary Outcomes

Change in depression and anxiety symptoms

Measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale (anxiety \& depression) ranges 0-21; higher scores = worse symptoms. Cutoff: ≥8 = probable case. Total score 0-42.

Time frame: Baseline, 8 weeks, and 12 weeks.

Change in functioning

Measured using the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item). Scores are summed and transformed to 0-100, with higher scores = greater disability / worse functioning.