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

NCT07235852 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Depression; Anxiety Disorders

Keywords

People living with HIV (PLHIV); Cognitive Behavioral Therapy (CBT); Culturally Adapted CBT (Ca-CBT); Feasibility Trial

Outcome Measures

Primary Outcomes (3)

• 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%).

  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%

  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%

  12 weeks post-intervention

Secondary Outcomes (8)

• Change in depression and anxiety symptoms

  Baseline, 8 weeks, and 12 weeks.

• Change in functioning

  Baseline, 8 weeks, 12 weeks.

• Change in internalized stigma

  Baseline, 8 weeks, 12 weeks.

• Change in ART adherence self-efficacy

  Baseline, 8 weeks, 12 weeks.

• Change in health-related quality of life

  Baseline, 8 weeks, 12 weeks.

Study Arms (2)

Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)

EXPERIMENTAL

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)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT) BEHAVIORAL

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

Culturally Adapted Cognitive Behavioral Therapy (Ca-CBT)

Treatment as Usual (TAU) OTHER

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

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Keele University: collaborator
• Hayatabad Medical Complex: collaborator

Study Sites (1)

Family Care Centre (FCC), Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Related Publications (12)

• 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.

  PMID: 10176779 BACKGROUND

• 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.

  PMID: 21604860 BACKGROUND

• 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.

  PMID: 11329393 BACKGROUND

• 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.

  PMID: 23866176 BACKGROUND

• 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.

  PMID: 28830574 BACKGROUND

• 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.

  PMID: 16943232 BACKGROUND

• 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.

  PMID: 20521205 BACKGROUND

• 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.

  PMID: 18444061 BACKGROUND

• 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.

  PMID: 28390407 BACKGROUND

• 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.

  PMID: 9794030 BACKGROUND

• 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.

  PMID: 31866326 BACKGROUND

• 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.

  PMID: 23351566 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huma Mughal, MPH, PhD

CONTACT

+44 7496 637532; h.mughal@keele.ac.uk

Dr Mian Mukhtar, MBBS, FCPS, FRCP UK

CONTACT

923005900339; Doctormian@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 19, 2025
• Study Start: September 15, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

PA (1)