Anxiety Disorders, Depression, HIV Infections
Conditions
Keywords
People living with HIV (PLHIV), Cognitive Behavioral Therapy (CBT), Culturally Adapted CBT (Ca-CBT), Feasibility Trial
Brief 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.
Detailed description
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.
Interventions
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.
OTHERTreatment as Usual (TAU)
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.
Sponsors
Khyber Medical University Peshawar
Keele University
Hayatabad Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors conducting outcome measurements will be blinded to treatment allocation (single-blind design). Randomization and allocation will be performed centrally by an independent researcher not involved in assessments or intervention delivery. Intervention therapists (HIV health workers) and participants will be aware of allocation due to the behavioral nature of the intervention. To reduce accidental unblinding, assessors will be trained to avoid discussing intervention content with participants and will document any instances where they suspect unblinding. Participant perceptions of allocation will be collected post-study to assess potential unblinding.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel arms (Ca-CBT vs Treatment as Usual). Randomization will use central, computer-generated permuted blocks (blocks of 4), administered by an independent researcher.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment - Enrollment Rate | Baseline to 12 weeks post-intervention. | 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%). |
| Feasibility of Intervention - Retention in Therapy | At the end of the 6-week intervention period | 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% |
| Feasibility of Data Collection - Follow-up Assessment Completion | 12 weeks post-intervention | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression and anxiety symptoms | Baseline, 8 weeks, and 12 weeks. | 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. |
| Change in functioning | Baseline, 8 weeks, 12 weeks. | 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. |
| Change in internalized stigma | Baseline, 8 weeks, 12 weeks. | Measured using the Brief Internalized Stigma of Mental Illness Scale (ISMI-10). Items scored 1-4, total range 10-40; higher scores = greater stigma. |
| Change in ART adherence self-efficacy | Baseline, 8 weeks, 12 weeks. | Measured using the HIV Adherence Self-Efficacy Scale (HIV-ASES). Items rated 1-10; higher scores = greater self-efficacy for ART adherence. |
| Change in health-related quality of life | Baseline, 8 weeks, 12 weeks. | 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). |
| Change in trauma symptoms | Baseline, 8 weeks, 12 weeks. | 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. |
| Intervention fidelity | Baseline, 8 weeks, 12 weeks. | Measured using the Revised Cognitive Therapy Scale (CTS-R). Each item scored 0-6; total mean score ≥3 indicates adequate competence. |
| Acceptability of intervention | Baseline, 8 weeks, 12 weeks. | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORHuma Mughal, MPH,PhD*
Keele University
PRINCIPAL_INVESTIGATORProf Monica Magadi, PhD
Keele University
PRINCIPAL_INVESTIGATORDr James Prior, PhD
Keele University
PRINCIPAL_INVESTIGATORProf Saeed Farooq, PhD
Keele University
PRINCIPAL_INVESTIGATORDr Shaista Rasool, PhD
Khyber Medical University
PRINCIPAL_INVESTIGATORDr Mirat Gul, PhD
Mayo Hospital Lahore
Outcome results
None listed