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

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ClinicalTrials.gov Identifier: NCT01534338
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
David S. Black, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 16, 2012
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
Sleep [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
Sleep [ Time Frame: Within 2 weeks post-intervention ]
Primary sleep outcomes to be assessed include objective parameters (i.e., wrist actigraphy) and subjective parameters (i.e., Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, and Pre-Sleep Arousal Scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Mindfulness [ Time Frame: 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
  • Inflammatory Biology [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
  • Mindfulness [ Time Frame: 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
  • Inflammatory Biology [ Time Frame: Within 2 weeks post-intervention ]
    Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems
Official Title  ICMJE A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Problems
  • Inflammation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness Meditation
  • 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.
    Intervention: Behavioral: Sleep Education
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
48
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2012)
80
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534338
Other Study ID Numbers  ICMJE MH019925
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David S. Black, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David S Black, M.P.H., Ph.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP