Cognitive-Based Compassion Training (CBCT) for People Living With HIV (PLHIV)

Emory University

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Cognitive-Based Compassion Training (CBCT); Behavioral: Health discussion

Study type: Interventional

Funder types: Other

Identifiers

NCT02395289

IRB00075221

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Cognitive-Based Compassion Training (CBCT)

Experimental group

Description:

HIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to receive an 8-week program of Cognitive-Based Compassion Training (CBCT).

Treatment:

Behavioral: Cognitive-Based Compassion Training (CBCT)

Health Discussion Control

Active Comparator group

Description:

HIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to attend a health discussion group for 8 weeks.

Treatment:

Behavioral: Health discussion