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Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. This is the first intervention trial in AD caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging
This randomized controlled trial aims to evaluate the non-inferiority of Mindful Awareness Practices for Insomnia (MAP-I ) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I) on outcomes of insomnia, cellular and genomic markers of inflammation, and cellular aging in older adult AD spousal caregivers with insomnia (N=150) over one-year follow-up. The specific aims of this project are:
Primary Aim 1: Determine the effects of MAP-I vs. CBT-I on subjective and objective dimensions of insomnia.
Secondary Aim 1: Evaluate the effects of MAP-I vs. CBT-I on cellular and genomic markers of inflammation.
Secondary Aim 2: Evaluate the effects of MAP-I vs. CBT-I on markers of cellular aging.
Exploratory Aim 1: Explore moderating effects of caregiver stress (Stress and Adversity Inventory, STRAIN, number & experienced intensity of stress exposure) on insomnia outcomes, and effects of MAP-I vs. CBT-I on caregiver stress, health functioning, chronic medical morbidity and related medication use at follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Active Comparator | Cognitive behavioral therapy for insomnia (CBT-I), considered the treatment of choice by the American Academy of Sleep Medicine, combines cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation to improve sleep outcomes, with demonstrated efficacy in adult and older adult populations |
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| MAP-I | Experimental | The Mindful Awareness Practices (MAPs) is a validated and curriculum-based meditation similar to Mindfulness Based Stress Reduction, with the exception that MAPs does not include a day-long retreat or yoga and hence takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life. (http://marc.ucla.edu) MAP for Insomnia (MAP-I) is a modified version of MAPs that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | CBT-I is a behavioral treatment for insomnia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia clinical response | Change in severity of insomnia as measured by the Insomnia Severity Index | One-year |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia clinical response | Change in severity of insomnia as measured by clinical diagnosis | One year |
| Daytime dysfunction | Change in depressed mood as measured by the Inventory of Depressive Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Irwin, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Randomized, non-inferiority design
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Outcome assessor is blind to treatment condition
| MAP-I |
| Behavioral |
MAP-I is a mindfulness meditation treatment for insomnia |
|
| One year |
| Inflammation | Change in markers of systemic inflammation as measured by C-reactive protein | One year |
| Cellular aging | Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP) | One year |
| D001523 |
| Mental Disorders |