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)
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Rahim Yar Khan、Punjab Province、パキスタン、64200
- Sheikh Zayed Hospital Rahim Yar Khan
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HIV Stigma Scale
時間枠：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
|
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The Depression Anxiety Stress Scales (DASS) 21
時間枠：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
|
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Psychological well-being scale
時間枠：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
|
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Multidimensional Perceived Social Support Scale (MPSS)
時間枠：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
|
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The Mini-Mental State Examination
時間枠：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
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Dr Arsalan khalid, phd psycholoogy、The islamia university of Bahawalpur
- 主任研究者：Sadia Batool, phd applied psychology、The islamia university of Bahawalpur
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- F22BAPSY4M01006
- 388//IRB/SZMC/SZH (その他の助成金/資金番号：Sheikh zayed Medical college hospital. RYK)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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