An interventional study of Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT) and Treatment as Usual (TAU) in HIV Infections, Depression and Anxiety Disorders, sponsored by Khyber Medical University Peshawar. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Other
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.
This feasibility pilot trial aims to evaluate the acceptability and feasibility of a culturally adapted cognitive behavioral therapy (Ca-CBT) intervention for PLHIV with comorbid depression or anxiety in Pakistan. The study will be conducted at the Family Care Centre (FCC), Hayatabad Medical Complex, Peshawar, which provides HIV diagnosis, registration, treatment, and adherence counselling.
Fifty eligible participants aged 18-65, living with HIV, and meeting the Hospital Anxiety and Depression Scale (HADS) thresholds will be randomized (1:1) to intervention or treatment as usual. The intervention group will receive six consecutive sessions of Ca-CBT, designed to improve depression, anxiety, adherence to ART, and functionality. Sessions will use culturally relevant materials, metaphors, and self-help tools, tailored for low-literacy populations. Delivery will be by HIV health workers trained and supervised under a cascade model.
Primary feasibility outcomes include recruitment, retention, completion of therapy sessions, fidelity of delivery, and acceptability. Secondary outcomes include changes in depression (HADS), functioning (WHODAS), internalized stigma, ART adherence self-efficacy, health-related quality of life (EQ-5D), and trauma symptoms. Assessments will occur at baseline, 8 weeks (post-intervention), and 12 weeks (follow-up).
The trial uses a randomized, single-blind (assessors) two-arm design. Recruitment will draw from the FCC registry of HIV patients. Sample size justification follows CONSORT guidelines for feasibility trials, with traffic-light progression criteria (stop/amend/go thresholds) for decision-making on a definitive trial.
This study will provide essential data on feasibility, acceptability, and preliminary clinical signals to inform a full-scale RCT evaluating culturally adapted CBT for PLHIV in Pakistan.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 50 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Khyber Medical University Peshawar is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)
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.
Other: Treatment as Usual (TAU)
A six-session culturally adapted cognitive behavioral therapy (Ca-CBT) intervention designed for people living with HIV (PLHIV) with depression or anxiety. Sessions will last 45-60 minutes each, delivered weekly by trained HIV health workers under professional supervision. The intervention incorporates culturally relevant stories, metaphors, and self-help audio/video materials, tailored for low-literacy populations. The therapy focuses on reducing depression and anxiety, improving functioning, enhancing adherence to antiretroviral therapy (ART), and problem-solving skills.
Also known as: Culturally adapted CBT, CaCBT
Participants will receive routine HIV care as provided at Family Care Centres under the National HIV Control Program. This includes free initiation and continuation of antiretroviral therapy (ART), adherence counselling, regular health check-ups, and medication refills. No additional psychological therapy or behavioral intervention will be provided.
Also known as: Routine HIV care, Standard care under HIV Control Program
Feasibility of Recruitment - Enrollment Rate
The proportion of eligible participants who are successfully enrolled into the trial. This will be calculated as: (Number of participants enrolled / Number of eligible participants screened) \* 100%. Criteria: Proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%).
Time frame: Baseline to 12 weeks post-intervention.
Feasibility of Intervention - Retention in Therapy
The proportion of enrolled participants who complete at least 4 out of the 6 planned therapy sessions. This will be calculated as: (Number of participants completing ≥4 sessions / Total number of participants enrolled in the intervention arm) \* 100%. Criteria: proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%). Go: \>80%
Time frame: At the end of the 6-week intervention period
Feasibility of Data Collection - Follow-up Assessment Completion
The proportion of enrolled participants who complete the primary outcome assessments at the 12-week post-intervention time point. This will be calculated as: (Number of participants completing the 12-week assessment / Total number of participants enrolled) \* 100%. Criteria: proportion completing outcome assessments at 12 weeks (stop \<60%, amend 60-80%, go \>80%). Go: \>80%
Time frame: 12 weeks post-intervention
Change in depression and anxiety symptoms
Measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale (anxiety \& depression) ranges 0-21; higher scores = worse symptoms. Cutoff: ≥8 = probable case. Total score 0-42.
Time frame: Baseline, 8 weeks, and 12 weeks.
Change in functioning
Measured using the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item). Scores are summed and transformed to 0-100, with higher scores = greater disability / worse functioning.
Time frame: Baseline, 8 weeks, 12 weeks.
Change in internalized stigma
Measured using the Brief Internalized Stigma of Mental Illness Scale (ISMI-10). Items scored 1-4, total range 10-40; higher scores = greater stigma.
Time frame: Baseline, 8 weeks, 12 weeks.
Change in ART adherence self-efficacy
Measured using the HIV Adherence Self-Efficacy Scale (HIV-ASES). Items rated 1-10; higher scores = greater self-efficacy for ART adherence.
Time frame: Baseline, 8 weeks, 12 weeks.
Change in health-related quality of life
Measured using the EuroQol EQ-5D (5 domains, scored 1-3 or 1-5 depending on version; converted to index values 0 = death, 1 = perfect health; higher = better HRQoL). Includes EQ-VAS (0-100 scale).
Time frame: Baseline, 8 weeks, 12 weeks.
Change in trauma symptoms
Measured using the Harvard Trauma Questionnaire (HTQ). Items scored 1-4; mean score ≥2.5 suggests clinically significant PTSD symptoms. Higher scores = worse trauma symptoms.
Time frame: Baseline, 8 weeks, 12 weeks.
Intervention fidelity
Measured using the Revised Cognitive Therapy Scale (CTS-R). Each item scored 0-6; total mean score ≥3 indicates adequate competence.
Time frame: Baseline, 8 weeks, 12 weeks.
Acceptability of intervention
Measured using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each tool has 4 items scored 1-5; higher scores = greater acceptability, appropriateness, or feasibility.
Time frame: Baseline, 8 weeks, 12 weeks.
Plan to share: Yes — The Individual Participant Data (IPD) from this pilot feasibility trial will be shared with qualified researchers upon request. The dataset will include anonymized data on participant demographics, eligibility, baseline measures, outcome assessments (HADS, WHODAS, ISMI, HIV-ASES, etc.), and data related to the intervention (Ca-CBT or Treatment as Usual). The data sharing plan ensures that participant confidentiality is maintained in accordance with ethical standards, and the dataset will be accessible for further analyses related to mental health interventions for HIV-positive individuals. Data sharing will also be contingent upon institutional approval and the availability of resources for analysis. Access will be governed by ethical review board policies to protect participant privacy and confidentiality.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Khyber Medical University Peshawar