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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626949
• Other study ID #: GCO 13-1990
• Secondary ID: 1R21AT008540-01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 18, 2017

Study information

• Verified date: April 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 6 (IL-6) Biological Markers	Interleukin 6 (IL-6) biological markers at 8 weeks and 6 months as compared to baseline.	Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary	PROMIS - Anxiety	Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Measures of Psychosocial Stress, total scale 5-40 with higher score indicating more anxiety	Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary	PROMIS - Fatigue	Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue - Measures of Psychosocial Stress, total scale 5-40 with higher score indicating more fatigue	Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary	BDI-II	Beck Depression Inventory (BDI-II) - Measures of Psychosocial Stress, total scale from 0-63, with higher score indicating more depression	Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary	FFMQ	The Five Facet Mindfulness Questionnaire (FFMQ) - Measures of Mindfulness, full scale from 39 - 195, with higher score indicating more mindfulness	Baseline, 8 weeks post intervention, and 6 months post intervention
Secondary	Retention Rates	Attendance records will provide retention rates.	6 months