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

NCT01534338 | Completed Phase 1 DMC

• 1 other identifier: MH019925
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Problems; Inflammation

Keywords

Sleep; inflammation; mindfulness; meditation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mindfulness

  Within 2 weeks post-intervention

• Inflammatory Biology

  Within 2 weeks post-intervention

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

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

Sleep Education

ACTIVE COMPARATOR

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

Interventions

Mindfulness Meditation 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.

Mindfulness Meditation

Sleep Education 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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 25686304 DERIVED

MeSH Terms

Conditions

Parasomnias; Inflammation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• David S Black, M.P.H., Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 16, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (1)