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 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Intervention / Traitement
Description détaillée
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:
- CBT group (n=24): Standard care + 8 weeks of brief CBT
- ACT group (n=24): Standard care + 8 weeks of brief ACT
- 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
Type d'étude
Interventionnel
Inscription (Estimé)
72
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Punjab Province
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Rahim Yar Khan, Punjab Province, Pakistan, 64200
- Sheikh Zayed Hospital Rahim Yar Khan
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
HIV Stigma Scale
Délai: 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.
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Baseline; up to 8 weeks; up to 6 months post-baseline
|
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The Depression Anxiety Stress Scales (DASS) 21
Délai: 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
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Baseline; up to 8 weeks; up to 6 months post-baseline
|
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Psychological well-being scale
Délai: 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."
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Baseline; up to 8 weeks; up to 6 months post-baseline
|
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Multidimensional Perceived Social Support Scale (MPSS)
Délai: 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.
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Baseline; up to 8 weeks; up to 6 months post-baseline
|
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The Mini-Mental State Examination
Délai: 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.
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Baseline; up to 8 weeks; up to 6 months post-baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dr Arsalan khalid, phd psycholoogy, The islamia university of Bahawalpur
- Chercheur principal: Sadia Batool, phd applied psychology, The islamia university of Bahawalpur
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 novembre 2025
Achèvement primaire (Estimé)
15 décembre 2026
Achèvement de l'étude (Estimé)
15 décembre 2026
Dates d'inscription aux études
Première soumission
30 mai 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies à virus lents
- Infections à VIH
- Syndrome immunodéficitaire acquis
Autres numéros d'identification d'étude
- F22BAPSY4M01006
- 388//IRB/SZMC/SZH (Autre subvention/numéro de financement: Sheikh zayed Medical college hospital. RYK)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
my selected population is HIV aids patients and the data is highly confidential
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .