Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems (MAPS)
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| ClinicalTrials.gov Identifier: NCT01534338 |
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Recruitment Status :
Completed
First Posted : February 16, 2012
Last Update Posted : December 11, 2012
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Sponsor:
University of California, Los Angeles
Information provided by (Responsible Party):
David S. Black, University of California, Los Angeles
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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 Type : | Interventional (Clinical Trial) |
| 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 : | February 2012 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Sleep Disorders
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
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| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David S. Black, Principal Investigator, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01534338 History of Changes |
| Other Study ID Numbers: |
MH019925 |
| First Posted: | February 16, 2012 Key Record Dates |
| Last Update Posted: | December 11, 2012 |
| Last Verified: | December 2012 |
Keywords provided by David S. Black, University of California, Los Angeles:
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Sleep inflammation mindfulness meditation randomized controlled trial |
Additional relevant MeSH terms:
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Inflammation Dyssomnias Sleep Wake Disorders Parasomnias Pathologic Processes |
Nervous System Diseases Mental Disorders Neurologic Manifestations Signs and Symptoms |