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

Primary Purpose

Sleep Problems, Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation
Sleep Education
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problems focused on measuring Sleep, inflammation, mindfulness, meditation, randomized controlled trial

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Meditation

Sleep Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mindfulness
Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice
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

Full Information

First Posted
February 9, 2012
Last Updated
December 10, 2012
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01534338
Brief Title
Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems
Acronym
MAPS
Official Title
A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problems, Inflammation
Keywords
Sleep, inflammation, mindfulness, meditation, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education
Intervention Description
Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.
Primary Outcome Measure Information:
Title
Sleep
Description
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
Time Frame
Within 2 weeks post-intervention
Secondary Outcome Measure Information:
Title
Mindfulness
Description
Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice
Time Frame
Within 2 weeks post-intervention
Title
Inflammatory Biology
Description
Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am
Time Frame
Within 2 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Black, M.P.H., Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25686304
Citation
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.
Results Reference
derived

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

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