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N/A N=114 Randomized Single-blind Treatment

Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults

HIV

Enrolled (actual)
114
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Interleukin 6 (IL-6) Biological Markers — 2.24; 2.63; 2.53; 2.88 pg/mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MBSR Course (Behavioral); HEP Course (Behavioral)
Age
Adult, Older Adult · 45+ yrs
Sex
All
Sponsor
Icahn School of Medicine at Mount Sinai
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Interleukin 6 (IL-6) Biological Markers
2.24; 2.63; 2.53; 2.88; 2.89; 2.62
SECONDARY
PROMIS - Anxiety
18.7; 19.3; 15.1; 18.4; 15.9; 18.5
SECONDARY
PROMIS - Fatigue
21.2; 21.4; 16.8; 21.1; 18.8; 19.3
SECONDARY
BDI-II
15.0; 15.6; 9.7; 14.7; 9.7; 13.1
SECONDARY
FFMQ
135.7; 135.4; 144.3; 134.7; 145.3; 141.5
SECONDARY
Retention Rates
30; 36

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02626949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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