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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03538574
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date July 1, 2018
Completion date September 30, 2022

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