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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)

11. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

72

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: CBT + Standard Care
Behaviorální: CBT
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.
Behaviorální: ACT+ Standard Care
ACT
Experimentální: ACT+ Standard Care
Behaviorální: CBT
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.
Behaviorální: ACT+ Standard Care
ACT

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
HIV Stigma Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sadia Batool

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. listopadu 2025

Primární dokončení (Odhadovaný)

15. prosince 2026

Dokončení studie (Odhadovaný)

15. prosince 2026

Termíny zápisu do studia

První předloženo

30. května 2026

První předloženo, které splnilo kritéria kontroly kvality

11. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • F22BAPSY4M01006
  • 388//IRB/SZMC/SZH (Jiné číslo grantu/financování: Sheikh zayed Medical college hospital. RYK)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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