The Efficacy of Cognitive-Based Compassion Training for Enhancing Immune Restoration and Psychological Adaptation in Individuals Living With HIV Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)
研究概览
简要总结
The purpose of the study is to examine the effects of cognitive-based compassion training (CBCT), a meditative practice based on Buddhist teachings, on long term emotional well-being and immune system improvement with people living with Human Immunodeficiency Virus (PLHIV).
详细描述
The proposed study will investigate the efficacy of cognitive-based compassion training (CBCT), a contemplative technique based on the Tibetan Buddhist tradition of compassion meditation, for enhancing immune restoration and psychological resilience in people living with HIV-1 (PLHIV). Psychosocial stress has been associated with increased circulating concentrations of key inflammatory biomarkers. The patients with HIV must cope with the physical impact of HIV disease itself, the often complex treatment regimens and side effects of combination antiretroviral therapy (ART), illness-associated psychological and existential dilemmas, changes in social roles and lifestyle patterns relative to illness progression, social stigma, and financial and material resource concerns. This study aims to determine if engagement with CBCT is associated with reduced circulating concentrations of stress-related inflammatory biomarkers, improves HIV-related clinical outcomes and decreases stress in PLHIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects living with HIV-1 infection who have been on continuous ART for a minimum of 12 months and:
- •are followed longitudinally for their HIV healthcare at the Infectious Disease Program
- •meet criteria for immunological non-responsiveness as defined by adherence to ART and cluster of differentiation 4 (CD4) count <350 cells/μL despite complete virologic suppression (> 2 plasma HIV viral load (pVL) below the limit of detection including the most recent pVL prior to enrollment).
- •Ability to give informed consent.
- •Score at least 1 standard deviation above socioeconomic status (SES)-matched general population norms on Perceived Stress Scale (PSS)
排除标准
- •History of psychosis
- •HIV-related neurocognitive decline
- •Substance abuse within the last year
- •Documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dL
- •Known or possible pregnancy or attempting to become pregnant
- •BMI below 17 or above 30
- •Bipolar disorder
- •Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
- •Continuous ART for < 12 months
结局指标
主要结局
Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)
时间窗: screening, 8 weeks
The plasma concentrations of IL-6 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Change in plasma concentration of circulating inflammatory biomarker soluble cluster of differentiation 14 (sCD14)
时间窗: screening, 8 weeks
The plasma concentrations of sCD14 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
次要结局
- Change in scores on the Illness Cognition Questionnaire (ICQ)(Screening, 8 weeks)
- Change in scores on the Berger HIV Stigma Scale(Screening, 8 weeks)
- Change in scores on the World Assumptions Scale (WAS)(Screening, 8 weeks)
- Change in scores on the Rosenberg self-esteem scale(Screening, 8 weeks)
- Change in scores on the Perceived Stress Scale (PSS)(Screening, 8 weeks)
- Acceptance of Cognitive-Based Compassion Training (CBCT), measured by participant satisfaction(8 weeks)
- Change in serum levels of C-reactive protein (CRP)(Screening, 8 weeks)
- Change in scores on the General Well-Being (GWB) Schedule Scale(Screening, 8 weeks)
- Change in scores on the Life Regard Index - Revised (LRI-R).(Screening, 8 weeks)
研究者
Mehul Tejani
Assistant Professor
Emory University