Clinical trial NCT02626949: Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
Official title: Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
AIDS
Mindfulness
Mindfulness-based stress reduction
Stress
Intervention
Inflammation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-12-10
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 6 (IL-6) Biological Markers
timeFrame: Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary outcomes:
measure: PROMIS - Anxiety
timeFrame: Baseline, 8 weeks post intervention, and 6 months post intervention
measure: PROMIS - Fatigue
timeFrame: Baseline, 8 weeks post intervention, and 6 months post intervention
measure: BDI-II
timeFrame: Baseline, 8 weeks post intervention, and 6 months post intervention
measure: FFMQ
timeFrame: Baseline, 8 weeks post intervention, and 6 months post intervention
measure: Retention Rates
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Weiss, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York College of Podiatric Medicine
name: Peter Barbosa, PhD
role: PRINCIPAL_INVESTIGATOR
References: