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

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.

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).