Clinical trial NCT02395289: Cognitive-Based Compassion Training (CBCT) for People Living With HIV (PLHIV)
Official title: The Efficacy of Cognitive-Based Compassion Training for Enhancing Immune Restoration and Psychological Adaptation in Individuals Living With HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Cognitive-Based Compassion Training (CBCT)
HIV-related clinical outcomes
Stress and stress-related psychological adjustment
Stress-related inflammatory biomarkers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Ability to give informed consent.
3. Score at least 1 standard deviation above socioeconomic status (SES)-matched general population norms on Perceived Stress Scale (PSS)

Exclusion Criteria:

1. History of psychosis
2. HIV-related neurocognitive decline
3. Substance abuse within the last year
4. Documented history of cirrhosis or a total bilirubin ≥ 2.0 mg/dL
5. Known or possible pregnancy or attempting to become pregnant
6. BMI below 17 or above 30
7. Age \< 18
8. Bipolar disorder
9. Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
10. Continuous ART for \< 12 months

Primary outcomes:
measure: Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)
timeFrame: screening, 8 weeks
measure: Change in plasma concentration of circulating inflammatory biomarker soluble cluster of differentiation 14 (sCD14)
timeFrame: screening, 8 weeks
Secondary outcomes:
measure: Change in scores on the Perceived Stress Scale (PSS)
timeFrame: Screening, 8 weeks
measure: Change in scores on the General Well-Being (GWB) Schedule Scale
timeFrame: Screening, 8 weeks
measure: Change in scores on the Illness Cognition Questionnaire (ICQ)
timeFrame: Screening, 8 weeks
measure: Change in scores on the World Assumptions Scale (WAS)
timeFrame: Screening, 8 weeks
measure: Change in scores on the Life Regard Index - Revised (LRI-R).
timeFrame: Screening, 8 weeks
measure: Change in scores on the Rosenberg self-esteem scale
timeFrame: Screening, 8 weeks
measure: Change in scores on the Berger HIV Stigma Scale
timeFrame: Screening, 8 weeks
measure: Change in serum levels of C-reactive protein (CRP)
timeFrame: Screening, 8 weeks
measure: Acceptance of Cognitive-Based Compassion Training (CBCT), measured by participant satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital - Ponce De Leon Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Mehul Tejani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Titanji BK, Tejani M, Farber EW, Mehta CC, Pace TW, Meagley K, Gavegnano C, Harrison T, Kokubun CW, Negi SD, Schinazi RF, Marconi VC. Cognitively Based Compassion Training for HIV Immune Nonresponders-An Attention-Placebo Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):340-348. doi: 10.1097/QAI.0000000000002874.