NCT07235852Completed
Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 26 Sept 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Khyber Medical University Peshawar
- Diseases
- HIV
- NCT number
- NCT07235852
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 15 Sept 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving psychotherapy or antidepressant medication within the last 6 months.
Other illness
- 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).
- HIV-associated neurocognitive disorders (HAND) or severe complications of HIV preventing participation, as judged by treating physician.
Other
- Current suicidality (per WHO mhGAP) or suicide attempt within the last 2 years.
- Living in the same household as another study participant (to prevent contamination between arms).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Family Care Centre (FCC), Hayatabad Medical Complex Coordinator of this site? Confirm its status | Peshawar | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.