Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems (MAPS)

A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems

The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation

Study Overview

• Status: Completed
• Conditions: Inflammation; Sleep Problems
• Intervention / Treatment: Behavioral: Mindfulness Meditation; Behavioral: Sleep Education

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women (all races and ethnicities) 55 years of age and older
• Have current problems sleeping
• Fluent in English
• Able to understand and provide signed informed consent
• Willing to be randomly assigned to treatment condition

Exclusion Criteria:

• Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
• Individuals living outside of a 20 mile radius from the UCLA Medical Center
• Individuals with current substance dependence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mindfulness Meditation; The MAPs program is based on experiential training in mindfulness meditation offered at the UCLA Mindful Awareness Research Center (MARC). A certified UCLA instructor will provide didactic training in mindfulness meditation in a group-based setting. Participants will be guided through in-class meditation practices and will be assigned daily meditation homework. Active program components include sitting and walking somatosensory-focused meditation, audio-guided body scan meditation, and loving kindness meditation. Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary. In addition to the MAPs training, sleep hygiene material will also be presented to match the sleep hygiene material in the sleep education condition.	Behavioral: Mindfulness Meditation; Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.
ACTIVE_COMPARATOR: Sleep Education; The sleep education condition is founded on knowledge acquisition. In the sleep seminar condition, a trained health educator will provide didactic presentations on sleep, sleep hygiene, sleep problems, and potential solutions to sleep problems in a group-based setting. Active components of sleep education include increasing knowledge of sleep biology, identifying characteristics of healthy and unhealthy sleep, sleep problems, and self-monitoring of sleep behavior. Participants attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary. The health education condition is comparable to MAPs in terms of time, attention, group support, and participant expectancy of a benefit in sleep parameters.	Behavioral: Sleep Education; Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Primary sleep outcomes to be assessed include Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, Insomnia Severity Index, and Pre-Sleep Arousal Scale	Within 2 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness	Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice	Within 2 weeks post-intervention
Inflammatory Biology	Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am	Within 2 weeks post-intervention

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: David S Black, M.P.H., Ph.D., University of California, Los Angeles

Publications and helpful links

General Publications

• Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness meditation and improvement in sleep quality and daytime impairment among older adults with sleep disturbances: a randomized clinical trial. JAMA Intern Med. 2015 Apr;175(4):494-501. doi: 10.1001/jamainternmed.2014.8081.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (ESTIMATE): February 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: randomized controlled trial; Sleep; mindfulness; meditation; inflammation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Inflammation; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: MH019925