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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT01534338
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 4.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Problems; Inflammation	Behavioral: Mindfulness Meditation; Behavioral: Sleep Education	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Sleep [Within 2 weeks post-intervention]

   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

1. Mindfulness [Within 2 weeks post-intervention]

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

2. Inflammatory Biology [Within 2 weeks post-intervention]

   Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David S. Black, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT01534338
• Other Study ID Numbers: MH019925
• First Posted: Feb 16, 2012
• Last Update Posted: Dec 11, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by David S. Black, Principal Investigator, University of California, Los Angeles: Sleep; inflammation; mindfulness; meditation; randomized controlled trial
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Sleep Wake Disorders; Inflammation

Study Results

No Results Posted as of Dec 11, 2012