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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David S. Black, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01534338
First received: February 9, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Sleep Problems
Inflammation
Behavioral: Mindfulness Meditation
Behavioral: Sleep Education
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Sleep [ Time Frame: Within 2 weeks post-intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 2 weeks post-intervention ] [ Designated as safety issue: No ]
    Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice

  • Inflammatory Biology [ Time Frame: Within 2 weeks post-intervention ] [ Designated as safety issue: No ]
    Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am


Enrollment: 48
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534338

Locations
United States, California
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
  More Information

Additional Information:
No publications provided

Responsible Party: David S. Black, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01534338     History of Changes
Other Study ID Numbers: MH019925
Study First Received: February 9, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Sleep
inflammation
mindfulness
meditation
randomized controlled trial

Additional relevant MeSH terms:
Dyssomnias
Inflammation
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014