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

NCT07652918 | Active Not Recruiting DMC

• 2 other identifiers: F22BAPSY4M01006388//IRB/SZMC/SZH
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV - Human Immunodeficiency Virus; Psychological Distress

Outcome Measures

Primary Outcomes (5)

• HIV Stigma Scale

  The 40-item HSS scale was first created by Berger et al. in 2001. Saif and Shehzad (2020) translated and verified it into an Urdu form. For this investigation, the HSS Urdu version will be utilized. Four components are evaluated by the HSS: public opinions, disclosure concerns, unfavorable self-image, and individualized stigma. A 4-point Likert-type scale, ranging from "strongly disagree" to "strongly agree," is used to score each item. The range of HSS scores is 40 to 160. Higher scores signify a high level of stigma. The HSS is a legitimate and trustworthy measure with strong psychometric qualities.

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

• The Depression Anxiety Stress Scales (DASS) 21

  The Depression Anxiety Stress Scale (DASS) was developed by Dr. Sydney H. Lovibond and Dr. Peter F. Lovibond in 1995 (Lovibond \& Lovibond, 1995) as a brief tool to measure the levels of depression, anxiety, and stress in individuals. The DASS-21 is a shortened version of the original 42-item DASS, with 21 items divided equally among the three scales, allowing for efficient assessment while maintaining accuracy. Each item is rated on a four-point Likert scale (from "did not apply to me at all" to "applied to me very much"), reflecting the frequency and intensity of negative emotional symptoms over the past week. The DASS-21 has demonstrated strong reliability, with Cronbach's alpha values typically reported around 0.88 for depression, 0.82 for anxiety, and 0.90 for stress. This high reliability makes it a widely accepted tool in both clinical and research settings for quickly identifying and differentiating symptoms of depression, anxiety, and stress. Psychologists utilize the Depressi

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

• Psychological well-being scale

  The Psychological Well-Being Scale (PWB) was developed by Dr. Carol D. Ryff in 1995 to measure multiple facets of positive functioning and overall psychological well-being (Ryff, 1995). The 33 components make up the modified SPWB measure. There are six sub-scales for each of the six positive functioning elements. The autonomy subscale evaluates a person's feeling of independence and self-determination. There are five things in it, such as "I tend to be influenced by people with strong opinions."

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

• Multidimensional Perceived Social Support Scale (MPSS)

  Zimet et al. (1988) created MPSS initially. Akhtar et al. (2010) translated and verified it into an Urdu version. The MPSS version that is being used for this investigation is Urdu. The 12-item, unidimensional MPSS measures an individual's perception of their social support network, which consists of friends, family, and significant others. A 7-point rating system, ranging from "strongly disagree" to "strongly agree," is used for each issue. A greater degree of social support is indicated by a higher score. MPSS has an overall reliability of \>0.80, with subscale reliability of 0.82, 0.86, and 0.86, respectively.

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

• The Mini-Mental State Examination

  The Mini-Mental State Examination (MMSE) is one of the most frequently used and extensively studied concerning precision and accuracy. MMSE was developed by Folstein M.F., in 1975. The test can be administered to individuals who are 18-85 years or older. It is an 11-question measure that tests 5 areas of cognitive function: Orientation, Registration, Attention and Calculation, Recall, and Language. A score of 23 or less has generally been accepted as indicating the presence of cognitive impairment.

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

Study Arms (2)

CBT + Standard Care

EXPERIMENTAL

CBT + Standard Care

Behavioral: CBT; Behavioral: ACT+ Standard Care

ACT+ Standard Care

EXPERIMENTAL

ACT+ Standard Care

Behavioral: CBT; Behavioral: ACT+ Standard Care

Interventions

CBT BEHAVIORAL

Participants receive standard ART care plus 8 weekly sessions of brief Cognitive Behavioral Therapy, 35-40 minutes each. CBT focuses on identifying/challenging negative thoughts, behavioral activation, and coping strategies. Delivered by Master's-level therapist trained in CBT, culturally adapted for HIV/AIDS patients.

ACT+ Standard Care; CBT + Standard Care

ACT+ Standard Care BEHAVIORAL

ACT

ACT+ Standard Care; CBT + Standard Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sadia Batool: lead

Study Sites (1)

Sheikh Zayed Hospital Rahim Yar Khan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Dr Arsalan khalid, phd psycholoogy

  The Islamia University of Bahawalpur

  PRINCIPAL INVESTIGATOR

• Sadia Batool, phd applied psychology

  The islamia university of Bahawalpur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Scholar

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 17, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)