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

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 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).

Conditions4

Browse More Trials