Actively Recruiting
Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
Led by Khyber Medical University Peshawar · Updated on 2025-11-19
50
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
K
Khyber Medical University Peshawar
Lead Sponsor
K
Keele University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- Pakistani nationals and residents
- Confirmed HIV diagnosis (newly diagnosed or on ART within 1 month of diagnosis, or on lifelong ART)
- Meeting Hospital Anxiety and Depression Scale (HADS) criteria: depression and anxiety subscale scores greater than 8, and total HADS score greater than 15
- HIV patients with comorbid conditions like Hepatitis or HCV if HIV is the primary condition
You will not qualify if you...
- Diagnosis of bipolar disorder, psychosis, or other severe mental illness
- Evidence of learning disability or severe substance use disorder (except nicotine)
- Receiving psychotherapy or antidepressant medication within the last 6 months
- Current suicidality or suicide attempt within the last 2 years
- HIV-associated neurocognitive disorders or severe HIV complications preventing participation
- Living in the same household as another study participant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Family Care Centre (FCC), Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
Actively Recruiting
Research Team
H
Huma Mughal, MPH, PhD
CONTACT
D
Dr Mian Mukhtar, MBBS, FCPS, FRCP UK
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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