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NCT02626949 · ClinicalTrials.gov registry record · NA
Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
A NA study of HIV, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT02626949: Completed NA study of HIV, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02626949 is a NA study of HIV that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 84 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02626949, a NA study of HIV, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study 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 med
Primary Outcome
Interleukin 6 (IL-6) biological markers at 8 weeks and 6 months as compared to baseline.
Conditions Studied
Interventions
- BEHAVIORAL MBSR Course
- BEHAVIORAL HEP Course
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-12-18 |
| Phase | NA |
What the finished NCT02626949 record still lists
NCT02626949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (81% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which MBSR Course is the first listed.
NCT02626949 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02626949 about?
NCT02626949 is a clinical study titled "Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults". 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...
What is the current status of trial NCT02626949?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2016-03. Estimated completion is 2017-12-18.
What conditions does trial NCT02626949 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT02626949?
The interventions under investigation include: MBSR Course (BEHAVIORAL), HEP Course (BEHAVIORAL).
Who is sponsoring clinical trial NCT02626949?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02626949 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02626949's enrollment target sits among peer trials
84 171st of 303 higher than 132 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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