NCT03538574

Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 45 Years – 95 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
BEHAVIORAL	CBT-I	CBT-I is a behavioral treatment for insomnia
BEHAVIORAL	MAP-I	MAP-I is a mindfulness meditation treatment for insomnia

Timeline

• Start date: 2018-07-01
• Primary completion: 2022-09-01
• Completion: 2022-09-30
• First posted: 2018-05-29
• Last updated: 2022-10-04

Locations

1 site across 1 country: United States