Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention (CHERISH)

November 17, 2025 updated by: Khyber Medical University Peshawar
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Recruiting
        • Family Care Centre (FCC), Hayatabad Medical Complex
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)
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)
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.
Other Names:
  • Culturally adapted CBT, CaCBT
Active Comparator: Treatment as Usual (TAU)
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)
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.
Other Names:
  • Routine HIV care, Standard care under HIV Control Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Recruitment - Enrollment Rate
Time Frame: 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%).
Baseline to 12 weeks post-intervention.
Feasibility of Intervention - Retention in Therapy
Time Frame: 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%
At the end of the 6-week intervention period
Feasibility of Data Collection - Follow-up Assessment Completion
Time Frame: 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%
12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression and anxiety symptoms
Time Frame: 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.
Baseline, 8 weeks, and 12 weeks.
Change in functioning
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.
Change in internalized stigma
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.
Change in ART adherence self-efficacy
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.
Change in health-related quality of life
Time Frame: 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).
Baseline, 8 weeks, 12 weeks.
Change in trauma symptoms
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.
Intervention fidelity
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.
Acceptability of intervention
Time Frame: 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.
Baseline, 8 weeks, 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Collaborators

Keele University
Hayatabad Medical Complex

Investigators

  • Principal Investigator: Huma Mughal, MPH,PhD*, Keele University
  • Principal Investigator: Prof Monica Magadi, PhD, Keele University
  • Principal Investigator: Dr James Prior, PhD, Keele University
  • Principal Investigator: Prof Saeed Farooq, PhD, Keele University
  • Principal Investigator: Dr Shaista Rasool, PhD, Khyber Medical University
  • Principal Investigator: Dr Mirat Gul, PhD, Mayo Hospital Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 25, 2026

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/DIR/CTU/2025/007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

he anonymized IPD will be made available within 6 months after the final study results have been published or upon completion of the trial's final analysis. The data will be shared for a minimum of 5 years after study completion for continued scientific exploration.

IPD Sharing Access Criteria

Researchers wishing to access the data will need to submit a request to the Principal Investigator or Study Coordinator. Data will be provided to individuals and institutions with ethical approval from an Institutional Review Board (IRB) or Ethics Committee (EC), ensuring adherence to all confidentiality and privacy guidelines. Access will be provided under terms of a data use agreement (DUA) to guarantee appropriate and responsible use of the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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