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

NCT ID: NCT01534338

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Sleep Problems Inflammation

Keywords

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Sleep inflammation mindfulness meditation randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.

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.

Group Type ACTIVE_COMPARATOR

Sleep Education

Intervention Type BEHAVIORAL

Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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David S. Black

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Black, M.P.H., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25686304 (View on PubMed)

Other Identifiers

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MH019925

Identifier Type: -

Identifier Source: org_study_id