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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Family Care Centre (FCC), Hayatabad Medical Complex
RECRUITING
Peshawar
Contact Information
Primary
Huma Mughal, MPH, PhD
h.mughal@keele.ac.uk
+44 7496 637532
Backup
Dr Mian Mukhtar, MBBS, FCPS, FRCP UK
Doctormian@yahoo.co.uk
923005900339
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-05-25
Participants
Target number of participants: 50
Treatments
Experimental: Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)
Participants randomized to this arm will receive a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention delivered by trained HIV health workers. The therapy will consist of six consecutive sessions, each approximately 45-60 minutes, focusing on reducing depression and anxiety symptoms, improving functionality, adherence to antiretroviral therapy (ART), and problem-solving skills. Intervention materials will include culturally relevant stories, metaphors, and self-help audio/video resources, tailored for low-literacy populations.
Active_comparator: Treatment as Usual (TAU)
Participants randomized to this arm will continue to receive routine HIV care as per the HIV Control Program guidelines. This includes free ART initiation and continuation, regular medical check-ups, medication refills, and adherence counselling provided at the Family Care Centre (FCC), Hayatabad Medical Complex, Peshawar. No additional psychological intervention will be provided in this arm.
Related Therapeutic Areas
Sponsors
Collaborators: Keele University, Hayatabad Medical Complex
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov