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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Human Immunodeficiency Virus
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Health discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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.
- First posted23 Mar 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehul Tejani, Emory University
- Investigators
- Mehul Tejani, MD, Principal investigator, Emory University
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cognitive-Based Compassion Training for Enhancing Immune Restoration and Psychological Adaptation in Individuals Living With HIV Disease
- ClinicalTrials.gov ID
- NCT02395289
- Acronym / sponsor ID
- IRB00075221
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Cognitive-Based Compassion Training (CBCT), HIV-related clinical outcomes, Stress and stress-related psychological adjustment, Stress-related inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Based Compassion Training (CBCT) | Experimental | Behavioral: Cognitive-Based Compassion Training (CBCT)HIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to receive an 8-week program of Cognitive-Based Compassion Training (CBCT). |
| Health Discussion Control | Active comparator | Behavioral: Health discussionHIV-1 positive subjects on antiretroviral therapy (ART) will be randomized to attend a health discussion group for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects living with HIV-1 infection who have been on continuous ART for a minimum of 12 months and:
- Ability to give informed consent.
- Score at least 1 standard deviation above socioeconomic status (SES)-matched general population norms on Perceived Stress Scale (PSS)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Based Compassion Training (CBCT)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. | Behavioural | Cognitive-Based Compassion Training (CBCT) |
| Health discussionHealth 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. | Behavioural | Health Discussion Control |
Primary outcome
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.
9 secondary outcomes
Change in scores on the Perceived Stress Scale (PSS)
Time frame: Screening, 8 weeks
Change in scores on the General Well-Being (GWB) Schedule Scale
Time frame: Screening, 8 weeks
Change in scores on the Illness Cognition Questionnaire (ICQ)
Time frame: Screening, 8 weeks
Change in scores on the World Assumptions Scale (WAS)
Time frame: Screening, 8 weeks
Change in scores on the Life Regard Index - Revised (LRI-R).
Time frame: Screening, 8 weeks
Change in scores on the Rosenberg self-esteem scale
Time frame: Screening, 8 weeks
Change in scores on the Berger HIV Stigma Scale
Time frame: Screening, 8 weeks
Change in serum levels of C-reactive protein (CRP)
Time frame: Screening, 8 weeks
Acceptance of Cognitive-Based Compassion Training (CBCT), measured by participant satisfaction
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 34879006Titanji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehul Tejani, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
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.