Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07235852

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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