University of Wisconsin Meditation & Exercise Cold Study

NCT01654289 | Completed Phase 2 Results DMC

• 2 other identifiers: 2012-0207R01AT006970
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise will lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza like illness. Specifically, this project aims to:

1. 1.Determine whether an 8-week training program in mindfulness meditation, as compared to the control group, will lead to significant reductions in incidence, duration, and severity of ARI illness.
2. 2.Determine whether an 8-week training program in moderate intensity sustained exercise, as compared to the control group, will lead to reductions in incidence, duration, and severity of ARI illness.
3. 3.Assess whether any observed reductions in ARI illness are accompanied by fewer ARI-related health care visits and less time lost to productive work (reduced absenteeism).
4. 4.Compare the potential benefits of mindfulness meditation to those from moderate intensity sustained exercise.
5. 5.Discern potential mediating factors and causal pathways that might help explain how these interventions lead to improved ARI illness-related outcomes.

Conditions

Acute Respiratory Infection

Keywords

respiratory tract infections; common cold; exercise; influenza; meditation

Outcome Measures

Primary Outcomes (1)

• Severity-weighted Total Days of ARI Illness

  The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.

  8 months

Secondary Outcomes (10)

• Absenteeism

  8 months

• Health Care Utilization

  8 months

• SF-12

  Baseline and 8 months (exit from study)

• Perceived Stress Scale (PSS-10)

  Baseline and 8 months (exit from study)

• Mindfulness-based Self Efficacy Scale (MSES)

  8 months (exit from study)

Study Arms (3)

Mindfulness Meditation

EXPERIMENTAL

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.

Other: Mindfulness Meditation

Exercise

EXPERIMENTAL

The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).

Other: Exercise

Wait-list control

NO INTERVENTION

Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.

Interventions

Mindfulness Meditation OTHER

Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.

Also known as: MBSR

Mindfulness Meditation

Exercise OTHER

Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.

Also known as: physical activity

Exercise

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 30-69 years at study entry.
• Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?"
• Prospective participants must meet the American Heart Association guidelines for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment.
• Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation, and to participate in blood draws, nasal wash, self-report questionnaires, and weekly monitoring for 9 months.
• A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study.
• Fluency and literacy in English language sufficient for understanding the study protocol and completing questionnaires.
• Successful completion of tasks during run-in period, including 2 in-person appointments, 1 phone contact, 1 set of homework questionnaires, and baseline nasal wash and blood draw.

You may not qualify if:

• Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice?
• Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the Behavioral Risk Factor Surveillance System (BRFSS) classification system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) \>4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week.
• Women who are pregnant at screening or plan to become pregnant during the course of the study (determined by self-report) will be excluded. Women who become pregnant any time during the course of the trial will not be dropped and will continue to be followed throughout the duration of the study.
• Physical, medical or mental condition(s) precluding adherence to study protocol. Conditions include: malignant disease (prospective participants' physicians to advise and Dr. Barrett, and/or designee Dr. Rakel or Dr. Muller, to make final decision); and function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). Questionable cases will be reviewed by the study physicians.
• True contraindication for influenza vaccine (flu shots) or refusal to accept influenza vaccine. Subjects will be asked to verify they have a) no known egg allergy, b) no prior reaction to influenza vaccine, and c) never been told they have Guillain-Barre Syndrome.
• Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed.
• Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease). Questionable cases will be reviewed by study physicians.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Wisconsin Department of Family Medicine

Madison, Wisconsin, 53715, United States

Location

Related Publications (3)

• Meyer JD, Torres ER, Grabow ML, Zgierska AE, Teng HY, Coe CL, Barrett BP. Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Med Sci Sports Exerc. 2018 Sep;50(9):1850-1858. doi: 10.1249/MSS.0000000000001636.

  PMID: 30113538 DERIVED

• Barrett B, Hayney MS, Muller D, Rakel D, Brown R, Zgierska AE, Barlow S, Hayer S, Barnet JH, Torres ER, Coe CL. Meditation or exercise for preventing acute respiratory infection (MEPARI-2): A randomized controlled trial. PLoS One. 2018 Jun 22;13(6):e0197778. doi: 10.1371/journal.pone.0197778. eCollection 2018.

  PMID: 29933369 DERIVED

• Goldstein E, Topitzes J, Brown RL, Barrett B. Mediational pathways of meditation and exercise on mental health and perceived stress: A randomized controlled trial. J Health Psychol. 2020 Oct;25(12):1816-1830. doi: 10.1177/1359105318772608. Epub 2018 May 7.

  PMID: 29733230 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold; Motor Activity; Influenza, Human

Interventions

Mindfulness; Exercise

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Behavior; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Bruce Barrett MD PhD
• Organization: University of Wisconsin

bruce.barrett@fammed.wisc.edu

608-263-2220

Study Officials

• Bruce Barrett, MD PhD

  University of Wisconsin Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-10

Locations

US (1)