NCT02395289

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

March 17, 2015

Last Update Submit

January 30, 2017

Conditions

Human Immunodeficiency Virus

Keywords

Cognitive-Based Compassion Training (CBCT)HIV-related clinical outcomesStress and stress-related psychological adjustmentStress-related inflammatory biomarkers

Outcome Measures

Primary Outcomes (2)

  • Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6)

    The plasma concentrations of IL-6 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.

    screening, 8 weeks

  • Change in plasma concentration of circulating inflammatory biomarker soluble cluster of differentiation 14 (sCD14)

    The plasma concentrations of sCD14 will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.

    screening, 8 weeks

Secondary Outcomes (9)

  • Change in scores on the Perceived Stress Scale (PSS)

    Screening, 8 weeks

  • Change in scores on the General Well-Being (GWB) Schedule Scale

    Screening, 8 weeks

  • Change in scores on the Illness Cognition Questionnaire (ICQ)

    Screening, 8 weeks

  • Change in scores on the World Assumptions Scale (WAS)

    Screening, 8 weeks

  • Change in scores on the Life Regard Index - Revised (LRI-R).

    Screening, 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Cognitive-Based Compassion Training (CBCT)

EXPERIMENTAL

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

Behavioral: Cognitive-Based Compassion Training (CBCT)

Health Discussion Control

ACTIVE COMPARATOR

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

Behavioral: Health discussion

Interventions

Cognitive-Based Compassion Training (CBCT)BEHAVIORAL

Cognitive-Based Compassion Training (CBCT) is composed of secular, didactic instruction and meditation practices. CBCT includes the meditative practices of developing one-pointed concentration and mindfulness. CBCT will be one class per week, 2 hours each, for 8 weeks, for a total of 16 hours during the study. Each meditation class will include a didactic and discussion session that will describe the meditative technique introduced during the week and a practice meditation session. The training protocol is highly iterative and techniques introduced early in training are practiced daily. All participants will be asked to meditate approximately 30 minutes a day "at home" and will be given a meditation diary to record amount of time spent meditating per week.

Cognitive-Based Compassion Training (CBCT)
Health discussionBEHAVIORAL

Health discussion therapy is one class per week, 2 hours each, for 8 weeks. Each class will use interactive teaching methods to present the health material in an engaging and relevant manner. Representative weekly topics that will be covered include healthy diet, the role of exercise in emotional health, and the importance of sleep and relaxation. It is important to note that the material presented in the health discussion group, although intended to be beneficial to participants, does not include a contemplative component and is not iterative in nature.

Health Discussion Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Age \< 18
  • Bipolar disorder
  • Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
  • Continuous ART for \< 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

  • 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.

    PMID: 34879006DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mehul Tejani, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 23, 2015

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)