Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 1/7/2018 |
| Start Date: | March 2016 |
| End Date: | December 18, 2017 |
By 2015 half of the people living with HIV infection in the U.S. are estimated be over the
age of 50, and this cohort of patients with well-controlled plasma viremia is aging at a more
rapid pace than their non-HIV peers. Long-term chronic inflammation plays a critical role in
premature aging in HIV-infected adults. Markers associated with chronic inflammation,
including IL-6, CRP, sCD14 and d-dimer, have not only been shown to be present at higher
levels in HIV-infected adults, but are also correlated to a wide variety of morbidities and
mortality. The goal of this project is to determine the impact of two different interventions
-- Mindfulness-Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) -- on
reducing biological markers associated with chronic inflammation in HIV-infected adults with
an undetectable HIV viral load. In order to achieve this goal, a pilot RCT with 120 subjects
over 50 years old who are on anti-retroviral therapy (ART) will be conducted with the
following specific aims: 1) to assess the effect of MBSR and/or HEP on biomarkers of chronic
inflammation (IL-6, CRP, sCD14, d-dimer), and, 2) to explore whether changes in psychological
well-being (anxiety, depression, fatigue, cognitive functioning) mediate the impact on
chronic inflammation. Subjects will be randomized to participation in a group MBSR course or
to the HEP group both of which consist of 8 weekly sessions followed by 6 monthly booster
sessions. Three time points will be measured: baseline, 8 weeks (immediately after completion
of weekly intervention), and 6-months post-completion of weekly intervention. Mixed linear
and structural equation model will be used to test the study hypotheses. The proposed study
is innovative in that it is the first to explore the impact of a complementary mind-body
intervention on chronic inflammation in HIV-infected adults. Given that the consequences of
early aging in this cohort will be a burden on the health care system as well as a medical,
social and psychological burden on those living with HIV, the study has the potential to have
a major public health impact.
age of 50, and this cohort of patients with well-controlled plasma viremia is aging at a more
rapid pace than their non-HIV peers. Long-term chronic inflammation plays a critical role in
premature aging in HIV-infected adults. Markers associated with chronic inflammation,
including IL-6, CRP, sCD14 and d-dimer, have not only been shown to be present at higher
levels in HIV-infected adults, but are also correlated to a wide variety of morbidities and
mortality. The goal of this project is to determine the impact of two different interventions
-- Mindfulness-Based Stress Reduction (MBSR) and Health Enhancement Program (HEP) -- on
reducing biological markers associated with chronic inflammation in HIV-infected adults with
an undetectable HIV viral load. In order to achieve this goal, a pilot RCT with 120 subjects
over 50 years old who are on anti-retroviral therapy (ART) will be conducted with the
following specific aims: 1) to assess the effect of MBSR and/or HEP on biomarkers of chronic
inflammation (IL-6, CRP, sCD14, d-dimer), and, 2) to explore whether changes in psychological
well-being (anxiety, depression, fatigue, cognitive functioning) mediate the impact on
chronic inflammation. Subjects will be randomized to participation in a group MBSR course or
to the HEP group both of which consist of 8 weekly sessions followed by 6 monthly booster
sessions. Three time points will be measured: baseline, 8 weeks (immediately after completion
of weekly intervention), and 6-months post-completion of weekly intervention. Mixed linear
and structural equation model will be used to test the study hypotheses. The proposed study
is innovative in that it is the first to explore the impact of a complementary mind-body
intervention on chronic inflammation in HIV-infected adults. Given that the consequences of
early aging in this cohort will be a burden on the health care system as well as a medical,
social and psychological burden on those living with HIV, the study has the potential to have
a major public health impact.
The proposed study will be the first to examine any form of alternative or complementary
holistic therapy in older long-term HIV-infected persons with well-controlled plasma viremia.
It will also be the first mind-body study of HIV-infected adults to be conducted using the
most rigorous randomized controlled trial (RCT) design. From a translational medicine
perspective, this study is innovative in that it examines a comprehensive set of biological
markers specifically associated with chronic inflammation. No previous mind-body study has
specifically targeted a set of biological markers that not only have been proven to be
elevated in adults with HIV, but also been described as predictors of morbidity and overall
mortality. This would be the first study to explore whether improvements in markers of
psychosocial stress mediate the impact of the proposed interventions on chronic inflammation.
This study is innovative in its effort to move HIV care beyond the current focus on virologic
control, optimization of comorbid conditions, and encouragement of healthy lifestyle to
include active interventions that can address the state of chronic inflammation and immune
dysfunction underlying the early and accelerated aging process. Most bio-behavioral research
in HIV to date has understandably focused on patients with poor adherence to HIV medication
and treatment. This study is novel in its focus on highly adherent patients and the
significant changes in profiles of biological markers associated with chronic inflammation
documented in this cohort. The complementary medicine approach being studied has the
potential to be integrated into the existing healthcare paradigm for HIV-positive persons.
Specific Aims:
Aim 1: To assess the effect of MBSR and HEP on biomarkers of chronic inflammation (IL-6, CRP,
sCD14, d-dimer), in HIV-infected adults with well-controlled plasma viremia.
Aim 2: To explore whether changes in markers of psychosocial well-being (anxiety, depression,
fatigue, cognitive functioning) mediate the impact of these mind-body interventions on
chronic inflammation.
General Study Design: The proposed study is a prospective, randomized, clinical trial with
attention control under the direction of the dual PIs, a behavioral scientist and a
virologist. The study team is also made up of investigators from infectious diseases,
mind-body medicine, geriatrics, and biostatistics. Subjects will be randomized to
participation in an 8-week group MBSR course or to the Health Enhancement Program (HEP). The
study population will consist of 120 individuals, 50 years old or older, long-term (5 years
on ART or longer) HIV-infected adults with well-controlled plasma viremia and baseline IL-6
level of 1.17 pg/mL or greater. Randomization will be stratified to achieve balanced
distribution between the groups based on gender and study site. One cohort group will
participate in the 8-week MBSR course followed by six, once-per-month booster sessions, and
separate cohort group will participate in HEP, with additional monthly educational meetings
for six months. Both groups will be evaluated using two sets of measures: biological markers
associated with chronic inflammation (IL-6, CRP, sCD14, d-dimer) and measures of psychosocial
stress (anxiety, depression, fatigue, and mindfulness). Subjects will be assessed at three
time points: baseline, 8 weeks (immediately after completion of weekly interventions), and
6-months post weekly courses (immediately after completion of booster sessions). The
investigators will use mixed linear and structural equation model to test study hypotheses.
holistic therapy in older long-term HIV-infected persons with well-controlled plasma viremia.
It will also be the first mind-body study of HIV-infected adults to be conducted using the
most rigorous randomized controlled trial (RCT) design. From a translational medicine
perspective, this study is innovative in that it examines a comprehensive set of biological
markers specifically associated with chronic inflammation. No previous mind-body study has
specifically targeted a set of biological markers that not only have been proven to be
elevated in adults with HIV, but also been described as predictors of morbidity and overall
mortality. This would be the first study to explore whether improvements in markers of
psychosocial stress mediate the impact of the proposed interventions on chronic inflammation.
This study is innovative in its effort to move HIV care beyond the current focus on virologic
control, optimization of comorbid conditions, and encouragement of healthy lifestyle to
include active interventions that can address the state of chronic inflammation and immune
dysfunction underlying the early and accelerated aging process. Most bio-behavioral research
in HIV to date has understandably focused on patients with poor adherence to HIV medication
and treatment. This study is novel in its focus on highly adherent patients and the
significant changes in profiles of biological markers associated with chronic inflammation
documented in this cohort. The complementary medicine approach being studied has the
potential to be integrated into the existing healthcare paradigm for HIV-positive persons.
Specific Aims:
Aim 1: To assess the effect of MBSR and HEP on biomarkers of chronic inflammation (IL-6, CRP,
sCD14, d-dimer), in HIV-infected adults with well-controlled plasma viremia.
Aim 2: To explore whether changes in markers of psychosocial well-being (anxiety, depression,
fatigue, cognitive functioning) mediate the impact of these mind-body interventions on
chronic inflammation.
General Study Design: The proposed study is a prospective, randomized, clinical trial with
attention control under the direction of the dual PIs, a behavioral scientist and a
virologist. The study team is also made up of investigators from infectious diseases,
mind-body medicine, geriatrics, and biostatistics. Subjects will be randomized to
participation in an 8-week group MBSR course or to the Health Enhancement Program (HEP). The
study population will consist of 120 individuals, 50 years old or older, long-term (5 years
on ART or longer) HIV-infected adults with well-controlled plasma viremia and baseline IL-6
level of 1.17 pg/mL or greater. Randomization will be stratified to achieve balanced
distribution between the groups based on gender and study site. One cohort group will
participate in the 8-week MBSR course followed by six, once-per-month booster sessions, and
separate cohort group will participate in HEP, with additional monthly educational meetings
for six months. Both groups will be evaluated using two sets of measures: biological markers
associated with chronic inflammation (IL-6, CRP, sCD14, d-dimer) and measures of psychosocial
stress (anxiety, depression, fatigue, and mindfulness). Subjects will be assessed at three
time points: baseline, 8 weeks (immediately after completion of weekly interventions), and
6-months post weekly courses (immediately after completion of booster sessions). The
investigators will use mixed linear and structural equation model to test study hypotheses.
Inclusion criteria:
- HIV-infected for 5 or more years
- On ART for 5 or more years
- HIV viral load consistently <48 copies/mL for the last year
- No anticipated changes in ART by provider or patient
- Fluency in the English language
- Age 45 years or older
- Willingness to complete the entire MBSR or HEP interventions
Exclusion criteria:
- Having participated in an MBSR course in the past
- Current meditation and/or yoga practice
- Began psychiatric medications in the past 2 months or plans to discontinue psychiatric
medications
- Currently receiving steroids or immunosuppressant drugs
- Women who are pregnant or plan to become pregnant in the next year
We found this trial at
1
site
1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Jeffrey Weiss, PhD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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