Pilot test of a culturally adapted cognitive behavioral therapy for people living with HIV

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

This project will test whether a culturally adapted cognitive behavioral therapy delivered by trained HIV health workers helps adults living with HIV in Peshawar who have depression and anxiety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Khyber Medical University Peshawar (other)
• Locations: 1 site (Peshawar, Khyber Pakhtunkhwa)
• Trial ID: NCT07235852 on ClinicalTrials.gov

What this trial studies

This randomized, single-blind pilot feasibility trial will enroll 50 adults living with HIV and elevated depression and anxiety scores and randomize them 1:1 to six sessions of culturally adapted CBT (Ca-CBT) delivered by trained HIV health workers or to treatment as usual. The Ca-CBT uses culturally relevant metaphors, low-literacy materials, and self-help tools tailored for the local population and is delivered at the Family Care Centre, Hayatabad Medical Complex in Peshawar. Primary outcomes are feasibility and acceptability measures including recruitment, retention, session completion, and fidelity, with clinical measures (HADS, WHODAS, stigma, ART adherence self-efficacy, EQ-5D, trauma) collected at baseline, 8 weeks, and 12 weeks. Findings will inform whether a larger definitive trial of this task-shifted, culturally adapted intervention is warranted.

Who should consider this trial

Good fit: Adults aged 18–65 who are Pakistani residents with confirmed HIV infection and meet HADS thresholds for depression and anxiety (HADS subscales >8 and total HADS >15) are the intended participants.

Not a fit: People with bipolar disorder, psychosis, severe substance use disorder, current suicidality, recent psychotherapy or antidepressant use, severe cognitive impairment, or other conditions preventing participation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce depression and anxiety and improve daily functioning and ART adherence among people living with HIV in this setting.

How similar studies have performed: Task-shifted and culturally adapted CBT interventions have shown benefit for common mental disorders in other low- and middle-income settings, though evidence specific to PLHIV in Pakistan is limited.

Eligibility criteria

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).

Where this trial is running

Peshawar, Khyber Pakhtunkhwa

• Family Care Centre (FCC), Hayatabad Medical Complex — Peshawar, Khyber Pakhtunkhwa, Pakistan (RECRUITING)

Study contacts

• Principal investigator: Huma Mughal, MPH,PhD* — Keele University
• Study coordinator: Huma Mughal, MPH, PhD

Conditions: HIV Infections, Depression, Anxiety Disorders, People living with HIV, Cognitive Behavioral Therapy, Culturally Adapted CBT, Feasibility Trial