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

NCT02626949 | Completed Results DMC

• 2 other identifiers: GCO 13-19901R21AT008540-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; AIDS; Mindfulness; Mindfulness-based stress reduction; Stress; Intervention; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PROMIS - Anxiety

  Baseline, 8 weeks post intervention, and 6 months post intervention

• PROMIS - Fatigue

  Baseline, 8 weeks post intervention, and 6 months post intervention

• BDI-II

  Baseline, 8 weeks post intervention, and 6 months post intervention

• FFMQ

  Baseline, 8 weeks post intervention, and 6 months post intervention

• Retention Rates

  6 months

Study Arms (2)

MBSR Course

EXPERIMENTAL

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

HEP Course

EXPERIMENTAL

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

Interventions

MBSR Course BEHAVIORAL

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.

Also known as: Mindfulness meditation, Mindfulness-Based Stress Reduction

MBSR Course

HEP Course BEHAVIORAL

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.

Also known as: Health Enhancement Program

HEP Course

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Inflammation

Interventions

Mindfulness; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Jeffrey Weiss, PhD, MS
• Organization: Icahn School of Medicine at Mount Sinai

Jeffrey.Weiss@mountsinai.org

212-824-7575

Study Officials

• Jeffrey Weiss, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Peter Barbosa, PhD

  New York College of Podiatric Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: March 1, 2016
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Locations

US (1)