Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
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|ClinicalTrials.gov Identifier: NCT02626949|
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: MBSR Course Behavioral: HEP Course||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 18, 2017|
|Actual Study Completion Date :||December 18, 2017|
Experimental: MBSR Course
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2.5 hours each, and a 5 hour silent retreat during the 6th week of the program.
Behavioral: MBSR Course
Formal mindfulness meditation methods taught in the MBSR course include: Body Scan Meditation (a supine meditation), Gentle Hatha Yoga (practiced with mindful awareness of the body), Sitting Meditation (mindfulness of breath, body, feelings, thoughts, and emotions), and Walking Meditation. Informal Mindfulness Meditation Practices (mindfulness in everyday life) include: 1) awareness of pleasant and unpleasant events, and, 2) deliberate awareness of routine activities and events such as eating, weather, walking, and interpersonal communication. Daily home assignments include a minimum of 30 minutes daily formal mindfulness practices and 5-15 minutes informal practice, 6 days per week for the entire duration of the course. Course sessions will consist of discussions oriented around weekly homework assignments, including an exploration of obstacles, and development of self-regulatory skills and capacities.
Experimental: HEP Course
Health Enhancement Program (HEP) consisting of 8 weekly sessions, 2.5 hours each, and 1.5 hour monthly educational sessions after the 8 week intervention.
Behavioral: HEP Course
HEP is an active control that matches MBSR in non-specific factors, such as the amount of time participants interact, but does not include mindfulness practice as an active component. HEP instructors will be selected from experts in the areas covered: music, nutrition education, and, functional movement. The study's RC will coordinate HEP sessions and monitor attendance. Following the 8-week HEP protocol, subjects will meet monthly in 1.5-hour educational sessions to match the booster sessions of MBSR participants.
Other Name: Health Enhancement Program
- Composite Measurement of Biological Markers [ Time Frame: Baseline and 8 weeks post intervention ]
Change in biological markers at 8 weeks as compared to baseline. Composite includes:
- Interleukin 6 (IL-6)
- C-reactive protein (CRP)
- Soluble CD14 (sCD14)
- Composite Measurement of Biological Markers [ Time Frame: Baseline and 6-months post intervention ]
Change in biological markers at 6 months post intervention as compared to baseline. Composite includes:
- Interleukin 6 (IL-6)
- C-reactive protein (CRP)
- Soluble CD14 (sCD14)
- PROMIS [ Time Frame: Baseline and 8 weeks post intervention ]Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety and Fatigue - Measures of Psychosocial Stress
- PROMIS [ Time Frame: Baseline and 6-months post intervention ]Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety and Fatigue - Measures of Psychosocial Stress
- BDI-II [ Time Frame: Baseline and 8 weeks post intervention ]Beck Depression Inventory (BDI-II) - Measures of Psychosocial Stress
- BDI-II [ Time Frame: Baseline and 6-months post intervention ]Beck Depression Inventory (BDI-II) - Measures of Psychosocial Stress
- FFMQ [ Time Frame: Baseline and 8 weeks post intervention ]The Five Facet Mindfulness Questionnaire (FFMQ) - Measures of Mindfulness
- FFMQ [ Time Frame: Baseline and 6-months post intervention ]The Five Facet Mindfulness Questionnaire (FFMQ) - Measures of Mindfulness
- Retention Rates [ Time Frame: 8 weeks ]Attendance records will provide completion and retention rates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626949
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Jeffrey Weiss, PhD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Peter Barbosa, PhD||New York College of Podiatric Medicine|