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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems

Conditions
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Sleep Problems, Inflammation

Intervention / Treatment
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* Behavioral: Mindfulness Meditation
* Behavioral: Sleep Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation<br>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<br>* Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.<br>|
| Active Comparator: Sleep Education<br>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<br>* Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindfulness | Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice | Within 2 weeks post-intervention | 
| Inflammatory Biology | Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am | Within 2 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, inflammation, mindfulness, meditation, randomized controlled trial