Active — Not RecruitingNot Applicable

Comparison of Acceptance and Commitment Therapy and Cognitive Behavior Therapy: Managing Psychological Distress and Its Multifaceted Impact on Stigmatization, Psychological Wellbeing, Social Support and Treatment Adherence in HIV/AIDS Patients

Pakistan72 participantsStarted 2025-11-13

Plain-language summary

This is a randomized controlled trial comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) for HIV/AIDS patients at Sheikh Zayed Hospital. 72 adults, aged 18-40 on ART will be randomized to CBT group (n=24), ACT group (n=24), or control group (n=24). Interventions are 8 weekly sessions of 35-40 minutes. Primary outcomes are depression, anxiety, stress measured by DASS-21, plus stigma, psychological wellbeing, social support, and medication adherence. Assessments at baseline, post-intervention, and 6-month follow-up using DASS-21, PWB, MPSS, GMAS, and MMSE. Ethical approval obtained from IRB of Sheikh Zayed Hospital. Informed consent, confidentiality, and voluntary participation ensured.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must have a documented medical diagnosis of HIV/AIDS by a healthcare professional. * Participants should fall within a specified age range, typically from 18 years to 40 years older. * ACT and CBT treatments will be made available to participants who are receiving ART. * Participants must be actively receiving or seeking treatment and care for their HIV/AIDS condition at Sheikh Zayed Hospital. * Individuals must express their voluntary willingness to participate in the study and provide informed consent. Exclusion Criteria: * Individuals with severe cognitive impairments that would hinder their ability to engage in assessments or therapy sessions will be excluded. * Individuals with severe psychiatric conditions that require immediate specialized care beyond the scope of the study will be excluded. * Individuals with a history of prior participation in a similar cognitive behavior therapy intervention for HIV/AIDS will be excluded to avoid potential confounding effects from previous treatment experiences

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing Acceptance and Commitment Therapy with Cognitive Behavior Therapy specifically for HIV-related psychological distress — given my current mental health situation, which of these two approaches do you think might be a better fit for me, and is it worth discussing this study with a specialist?
2The trial is measuring things like stigma, depression, anxiety, social support, and even cognitive functioning through the Mini-Mental State Examination — do you think any of these areas are a particular concern for me right now that I should be actively addressing regardless of whether I join a study?
3Since this trial is listed as 'active not recruiting,' what does that mean for my chances of participating, and are there similar therapy-based programs or studies still open that you could refer me to?
4The trial isn't testing a drug — it's comparing two talk therapy approaches — so how does that change the risk picture compared to a medication trial, and are there any downsides to participating in this kind of psychological research I should still be aware of?
5If I can't join this specific trial, would you recommend I pursue ACT or CBT on my own outside of a study, and how might adding structured psychological support affect my overall HIV treatment adherence based on what you know about my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HIV Stigma Scale

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

The Depression Anxiety Stress Scales (DASS) 21

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

Psychological well-being scale

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

Multidimensional Perceived Social Support Scale (MPSS)

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

The Mini-Mental State Examination

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

Trial details

NCT IDNCT07652918

SponsorSadia Batool

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-15

View on ClinicalTrials.gov More HIV - Human Immunodeficiency Virus trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

HIV Stigma Scale

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

The Depression Anxiety Stress Scales (DASS) 21

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

Psychological well-being scale

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

Multidimensional Perceived Social Support Scale (MPSS)

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline

The Mini-Mental State Examination

Timeframe: Baseline; up to 8 weeks; up to 6 months post-baseline