The Efficacy of Cognitive-Based Compassion Training for Enhancing Immune Restoration and Psychological Adaptation in Individuals Living With HIV Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus
- Sponsor
- Emory University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Mehul Tejani
Assistant Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)
Time Frame: 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)
Time Frame: screening, 8 weeks
The plasma concentrations of sCD14 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.
Secondary Outcomes
- 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)