Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention (NCT07235852) | Clinical Trial Compass
CompletedNot Applicable
Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
Pakistan50 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Recruitment - Enrollment Rate
Timeframe: Baseline to 12 weeks post-intervention.
2
Feasibility of Intervention - Retention in Therapy
Timeframe: At the end of the 6-week intervention period
3
Feasibility of Data Collection - Follow-up Assessment Completion