Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
NCT ID: NCT07235852
Last Updated: 2025-11-19
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-15
2026-05-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Keele University
OTHER
Hayatabad Medical Complex
OTHER_GOV
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Huma Mughal, MPH,PhD*
Role: PRINCIPAL_INVESTIGATOR
Keele University
Prof Monica Magadi, PhD
Role: PRINCIPAL_INVESTIGATOR
Keele University
Dr James Prior, PhD
Role: PRINCIPAL_INVESTIGATOR
Keele University
Prof Saeed Farooq, PhD
Role: PRINCIPAL_INVESTIGATOR
Keele University
Dr Shaista Rasool, PhD
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical University
Dr Mirat Gul, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Hospital Lahore
Locations
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Family Care Centre (FCC), Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KMU/DIR/CTU/2025/007
Identifier Type: -
Identifier Source: org_study_id
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