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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 (HIV CBT ACT)

2026년 6월 11일 업데이트: Sadia Batool
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.

연구 개요

상태

모집하지 않고 적극적으로

상세 설명

Background & Rationale:

HIV/AIDS is a chronic condition with significant psychological burden. People living with HIV/AIDS experience high levels of depression, anxiety, stress, and stigma, which affect treatment adherence and quality of life. Both Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) are evidence-based interventions for psychological distress, but their comparative effectiveness in HIV/AIDS patients in Pakistan has not been evaluated. This study aims to compare ACT and CBT for managing psychological distress and improving stigma, wellbeing, social support, and medication adherence.

Objective:

To compare the effectiveness of brief Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in reducing psychological distress and improving stigmatization, psychological wellbeing, social support, and medication adherence among HIV/AIDS patients.

Study Design:

Randomized Controlled Trial with single-blind design. Participants will be allocated to three groups using a computer-generated randomization sequence:

  1. CBT group (n=24): Standard care + 8 weeks of brief CBT
  2. ACT group (n=24): Standard care + 8 weeks of brief ACT
  3. Control group (n=24): Standard care only, no specific psychological intervention

A pilot study with 15 participants will be conducted prior to the main trial.

Participants:

  • Inclusion: Adults aged 18-40 years with a documented HIV/AIDS diagnosis, receiving ART, actively seeking treatment at Sheikh Zayed Hospital, and providing informed consent.
  • Exclusion: Severe cognitive impairment, severe psychiatric conditions requiring specialized care, or prior participation in similar CBT/ACT interventions for HIV/AIDS.

Intervention:

Both ACT and CBT will be delivered as once-weekly sessions of 35-40 minutes for 8 weeks.

  • ACT focuses on acceptance, mindfulness, values, committed action, and cognitive diffusion.
  • CBT focuses on identifying/challenging negative thoughts, behavioral activation, and coping strategies.

Interventions will be culturally adapted and delivered by therapists with at least a Master's degree and training in CBT/ACT.

Outcome Measures:

Assessments at baseline, post-intervention, and 6-month follow-up using:

  • DASS-21: Depression, Anxiety, Stress Scale
  • Psychological Well-Being Scale (PWB): 6 domains of wellbeing
  • HIV Stigma Scale: To measure perceived stigma
  • Multidimensional Perceived Social Support Scale (MPSS): Urdu version
  • General Medication Adherence Scale (GMAS): Urdu version
  • Mini-Mental State Examination (MMSE): For cognitive screening

Data Collection & Analysis:

Data will be collected using self-report questionnaires. Ethical approval will be obtained from the IRB of Sheikh Zayed Hospital. Informed consent, confidentiality, and voluntary participation will be ensured. Data analysis will compare outcomes across the three groups to evaluate effectiveness.

Ethics:

The study complies with ethical standards for human research. Institutional approval and ongoing informed consent will be maintained. Participant anonymity and data protection will be rigorously enforced.

Duration:

Study duration is not specified in the excerpt, but involves 8-week intervention plus 6-month follow-up.

Institution:

Department of Applied Psychology, The Islamia University Bahawalpur. Principal Investigator: Sadia Batool, Ph.D. Applied Psychology

연구 유형

중재적

등록 (추정된)

72

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Punjab Province
      • Rahim Yar Khan, Punjab Province, 파키스탄, 64200
        • Sheikh Zayed Hospital Rahim Yar Khan

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: CBT + Standard Care
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
실험적: ACT+ Standard Care
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HIV Stigma Scale
기간: Baseline; up to 8 weeks; up to 6 months post-baseline
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
기간: Baseline; up to 8 weeks; up to 6 months post-baseline
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
기간: Baseline; up to 8 weeks; up to 6 months post-baseline
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)
기간: Baseline; up to 8 weeks; up to 6 months post-baseline
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
기간: Baseline; up to 8 weeks; up to 6 months post-baseline
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Dr Arsalan khalid, phd psycholoogy, The islamia university of Bahawalpur
  • 수석 연구원: Sadia Batool, phd applied psychology, The islamia university of Bahawalpur

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 13일

기본 완료 (추정된)

2026년 12월 15일

연구 완료 (추정된)

2026년 12월 15일

연구 등록 날짜

최초 제출

2026년 5월 30일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

my selected population is HIV aids patients and the data is highly confidential

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심리적 고통에 대한 임상 시험

CBT에 대한 임상 시험

구독하다