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HIV InfectionsCHERISHNCT07235852

Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention

A study testing Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT) and Treatment as Usual (TAU) in people with HIV Infections and Depression, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Depression, Anxiety Disorders
What is being tested?
Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT) and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePakistan
Study dates
15 Sep 2025to 25 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Family Care Centre (FCC), Hayatabad Medical Complex

    Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT), Treatment as Usual (TAU)
Keywords
People living with HIV (PLHIV), Cognitive Behavioral Therapy (CBT), Culturally Adapted CBT (Ca-CBT), Feasibility Trial
Medical subject headings
HIV Infections, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)Behavioural

    Also called Culturally adapted CBT, CaCBT

    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.

  • Treatment as Usual (TAU)Other

    Also called Routine HIV care, Standard care under HIV Control Program

    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.

Study groups in NCT07235852
Study groupRoleWhat they receive
Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)ExperimentalParticipants 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.
Receives: Behavioral: Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)
Treatment as Usual (TAU)Active comparatorParticipants 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.
Receives: Other: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%).

    Measured: Baseline to 12 weeks post-intervention.

  2. 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%

    Measured: At the end of the 6-week intervention period

  3. 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%

    Measured: 12 weeks post-intervention

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 8 weeks, and 12 weeks.

  2. 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.

    Measured: Baseline, 8 weeks, 12 weeks.

  3. 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.

    Measured: Baseline, 8 weeks, 12 weeks.

  4. 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.

    Measured: Baseline, 8 weeks, 12 weeks.

  5. 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).

    Measured: Baseline, 8 weeks, 12 weeks.

  6. 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.

    Measured: Baseline, 8 weeks, 12 weeks.

  7. Intervention fidelity

    Measured using the Revised Cognitive Therapy Scale (CTS-R). Each item scored 0-6; total mean score ≥3 indicates adequate competence.

    Measured: Baseline, 8 weeks, 12 weeks.

  8. 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.

    Measured: Baseline, 8 weeks, 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start15 Sep 2025
  3. Primary completion31 Mar 2026
  4. Study completion25 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235852
Sponsor's protocol ID
KMU/DIR/CTU/2025/007
Acronym
CHERISH
Status last verified
Jun 2026
First submitted
26 Sep 2025
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Anand S, Hanson K. Disability-adjusted life years: a critical review. J Health Econ. 1997 Dec;16(6):685-702. doi: 10.1016/s0167-6296(97)00005-2.

    PubMed 10176779

  • Benish SG, Quintana S, Wampold BE. Culturally adapted psychotherapy and the legitimacy of myth: a direct-comparison meta-analysis. J Couns Psychol. 2011 Jul;58(3):279-89. doi: 10.1037/a0023626.

    PubMed 21604860

  • Ciesla JA, Roberts JE. Meta-analysis of the relationship between HIV infection and risk for depressive disorders. Am J Psychiatry. 2001 May;158(5):725-30. doi: 10.1176/appi.ajp.158.5.725.

    PubMed 11329393

  • Chowdhary N, Jotheeswaran AT, Nadkarni A, Hollon SD, King M, Jordans MJ, Rahman A, Verdeli H, Araya R, Patel V. The methods and outcomes of cultural adaptations of psychological treatments for depressive disorders: a systematic review. Psychol Med. 2014 Apr;44(6):1131-46. doi: 10.1017/S0033291713001785. Epub 2013 Jul 19.

    PubMed 23866176

  • Degnan A, Baker S, Edge D, Nottidge W, Noke M, Press CJ, Husain N, Rathod S, Drake RJ. The nature and efficacy of culturally-adapted psychosocial interventions for schizophrenia: a systematic review and meta-analysis. Psychol Med. 2018 Apr;48(5):714-727. doi: 10.1017/S0033291717002264. Epub 2017 Aug 23.

    PubMed 28830574

  • Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol. 2006 Oct;35(5):1292-300. doi: 10.1093/ije/dyl129. Epub 2006 Aug 30.

    PubMed 16943232

  • Hodge DR, Jackson KF, Vaughn MG. Culturally sensitive interventions and health and behavioral health youth outcomes: a meta-analytic review. Soc Work Health Care. 2010;49(5):401-23. doi: 10.1080/00981381003648398.

    PubMed 20521205

  • Huey SJ Jr, Polo AJ. Evidence-based psychosocial treatments for ethnic minority youth. J Clin Child Adolesc Psychol. 2008 Jan;37(1):262-301. doi: 10.1080/15374410701820174.

    PubMed 18444061

  • Li W, Zhang L, Luo X, Liu B, Liu Z, Lin F, Liu Z, Xie Y, Hudson M, Rathod S, Kingdon D, Husain N, Liu X, Ayub M, Naeem F. A qualitative study to explore views of patients', carers' and mental health professionals' to inform cultural adaptation of CBT for psychosis (CBTp) in China. BMC Psychiatry. 2017 Apr 8;17(1):131. doi: 10.1186/s12888-017-1290-6.

    PubMed 28390407

  • Lloyd KR, Jacob KS, Patel V, St Louis L, Bhugra D, Mann AH. The development of the Short Explanatory Model Interview (SEMI) and its use among primary-care attenders with common mental disorders. Psychol Med. 1998 Sep;28(5):1231-7. doi: 10.1017/s0033291798007065.

    PubMed 9794030

  • Mir F, Mahmood F, Siddiqui AR, Baqi S, Abidi SH, Kazi AM, Nathwani AA, Ladhani A, Qamar FN, Soofi SB, Memon SA, Soomro J, Shaikh SA, Simms V, Khan P, Ferrand RA. HIV infection predominantly affecting children in Sindh, Pakistan, 2019: a cross-sectional study of an outbreak. Lancet Infect Dis. 2020 Mar;20(3):362-370. doi: 10.1016/S1473-3099(19)30743-1. Epub 2019 Dec 19.

    PubMed 31866326

  • van Loon A, van Schaik A, Dekker J, Beekman A. Bridging the gap for ethnic minority adult outpatients with depression and anxiety disorders by culturally adapted treatments. J Affect Disord. 2013 May;147(1-3):9-16. doi: 10.1016/j.jad.2012.12.014. Epub 2013 Jan 23.

    PubMed 23351566

Questions about this trial

What is this clinical trial studying?

A study testing Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT) and Treatment as Usual (TAU) in people with HIV Infections and Depression, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment - Enrollment Rate (time frame: Baseline to 12 weeks post-intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07235852, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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