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Human Immunodeficiency VirusNCT02395289

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

A study testing Cognitive-Based Compassion Training (CBCT) and Health discussion in people with Human Immunodeficiency Virus, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Cognitive-Based Compassion Training (CBCT) and Health discussion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Mar 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • Age < 18
  • Bipolar disorder
  • Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
  • Continuous ART for < 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Grady Hospital - Ponce De Leon Clinic

    Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: The Efficacy of Cognitive-Based Compassion Training for Enhancing Immune Restoration and Psychological Adaptation in Individuals Living With HIV Disease

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).

Read the 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.

Being tested
Cognitive-Based Compassion Training (CBCT), Health discussion
Keywords
Cognitive-Based Compassion Training (CBCT), HIV-related clinical outcomes, Stress and stress-related psychological adjustment, Stress-related inflammatory biomarkers
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Based Compassion Training (CBCT)Behavioural

    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.

  • Health discussionBehavioural

    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.

Study groups in NCT02395289
Study groupRoleWhat they receive
Cognitive-Based Compassion Training (CBCT)ExperimentalHIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to receive an 8-week program of Cognitive-Based Compassion Training (CBCT).
Receives: Behavioral: Cognitive-Based Compassion Training (CBCT)
Health Discussion ControlActive comparatorHIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to attend a health discussion group for 8 weeks.
Receives: Behavioral: Health discussion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: screening, 8 weeks

  2. 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.

    Measured: screening, 8 weeks

Secondary outcomes (9)
  1. Change in scores on the Perceived Stress Scale (PSS)

    The PSS is a 10-item scale that provides a general index of perceived psychological stress as this relates to a sense that one's life is experienced as unpredictable, uncontrollable, and overloaded. The subjects are asked to indicate how often they felt or thought a certain way and to score their responses on a scale from 0 to 4, where 0= Never and 4=Very Often. PSS is measured on a scale of 0 to 40, with higher scores reflecting greater perceived stress.

    Measured: Screening, 8 weeks

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

    The GWB is an 18-item self-report scale designed to measure subjective psychological well-being and distress. It includes six subscales (anxiety, depression, positive well-being, self-control, vitality, general health) and also yields an overall well-being score. The response format used a 6-grade Likert scale and the range of scores will be normalized from 0 to 100. The higher the score, the better the well-being of the participant.

    Measured: Screening, 8 weeks

  3. Change in scores on the Illness Cognition Questionnaire (ICQ)

    This ICQ is an 18-item self-report measure used to assess changes in illness appraisal. It includes three subscales that evaluate specific dimensions of illness cognitions. Each of the three scales (helplessness, acceptance and benefits) consists of 6 items that are rated according to a 4-point Likert scale to the extent of agreement (0= not at all, 1=somewhat, 2= to a large extent, 3= completely), producing a total score ranging from 0 to 72, with a higher score being indicative of more illness appraisal.

    Measured: Screening, 8 weeks

  4. Change in scores on the World Assumptions Scale (WAS)

    The WAS is a 32-item self-report instrument that measures core personal beliefs. Subscales tap specific core belief domains, including: benevolence of the impersonal world, benevolence of people, justice, controllability of life events, self-worth, self-controllability, and personal luck. Each of these scales consist of items that are rated according to a 6-point Likert-type scale bounded by 1 (strongly disagree) and 6 (strongly agree). The higher the score is indicative to a stronger belief.

    Measured: Screening, 8 weeks

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

    The LRI-R is a 28-item scale that provides an index of global personal meaning. It includes two subscales: framework (assesses one's sense of having a frame of reference from which to appraise one's life and goals), and fulfillment (evaluates the degree to which one perceives that life goals are being realized). Both of these scales consist of items that are rated according to a 3-point Likert scale (1= I agree, 2= I have no opinion and 3= I disagree) and scores on both subscales range between 14 and 42, for a total range of 28 and 84. In case of the framework subscale, a higher score indicates a higher degree of positive beliefs and goals. In case of the fulfillment subscale, a higher score indicates that persons see themselves in the process of fulfilling their beliefs and goals.

    Measured: Screening, 8 weeks

  6. Change in scores on the Rosenberg self-esteem scale

    The Rosenberg Self-esteem scale is a 10-item scale that provides a self-report index of self-esteem. Each item is rated according to a 4-point Likert scale with scores ranging from strongly agree to strongly disagree. The scale ranges from 0-30, with 30 indicating the highest score possible. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.

    Measured: Screening, 8 weeks

  7. Change in scores on the Berger HIV Stigma Scale

    The Berger HIV Stigma Scale is a 13-item self-report measure that evaluates perceptions of HIV stigma across three subscale domains, including distancing (concerns about avoidance by others), blaming (feelings of blame from others and internal shame relative to HIV), and discrimination (concerns about inequitable treatment because of HIV). Each item is rated according to a 4-point Likert scale with scores ranging from bounded by 1 (strongly disagree) and 4 (strongly agree). Endorsement of stigmatizing views yielded a higher score.

    Measured: Screening, 8 weeks

  8. Change in serum levels of C-reactive protein (CRP)

    The serum concentration of CRP will be assessed using commercial enzyme-linked immunoassay (ELISA) kits.

    Measured: Screening, 8 weeks

  9. Acceptance of Cognitive-Based Compassion Training (CBCT), measured by participant satisfaction

    Acceptance of the CBCT will be measured by positive responses on a participant satisfaction survey, developed specifically for the study, which will be conducted at the completion of the 8-week program.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395289
Sponsor's protocol ID
IRB00075221
Status last verified
Jan 2017
First submitted
17 Mar 2015
Last updated
1 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34879006

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Based Compassion Training (CBCT) and Health discussion in people with Human Immunodeficiency Virus, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma concentration of circulating inflammatory biomarker interleukin-6 (IL-6) (time frame: screening, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395289, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.

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