CARES: Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT03538574

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Insomnia Chronic	Behavioral: CBT-I Behavioral: MAP-I	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, non-inferiority designRandomized, non-inferiority design

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

Outcome assessor is blind to treatment condition

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBT-I 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	Behavioral: CBT-I CBT-I is a behavioral treatment for insomnia
Experimental: MAP-I 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.	Behavioral: MAP-I MAP-I is a mindfulness meditation treatment for insomnia

Arm

Intervention/Treatment

Active Comparator: CBT-I

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

Behavioral: CBT-I

CBT-I is a behavioral treatment for insomnia

Experimental: MAP-I

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.

Behavioral: MAP-I

MAP-I is a mindfulness meditation treatment for insomnia

Outcome Measures

Primary Outcome Measures

Insomnia clinical response [One-year]
Change in severity of insomnia as measured by the Insomnia Severity Index

Secondary Outcome Measures

Insomnia clinical response [One year]
Change in severity of insomnia as measured by clinical diagnosis
Daytime dysfunction [One year]
Change in depressed mood as measured by the Inventory of Depressive Symptoms
Inflammation [One year]
Change in markers of systemic inflammation as measured by C-reactive protein
Cellular aging [One year]
Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Alzheimer or other dementia caregivers
Older than 45 years of age
Self-identified as the principal person taking care of the patient with Alzheimer or other dementia
Diagnostic and Statistical Manual Criteria - 5 for Insomnia

Exclusion Criteria:

Psychiatric disorders including current major depressive disorder or other current DSM-5 psychiatric disorder (e.g. substance dependence) with the exception of anxiety disorder;
Psychotic symptoms;
Acute suicidal or violent behavior or history of suicide attempt within the last year
Other sleep disorders including current or lifetime history of sleep apnea, nocturnal myoclonus, phase-shift disorder as identified by SCID-5 and Duke Structured Interview for Sleep Disorders (DSISD)
Medical conditions such as acute or uncontrolled medical illness (e.g., major surgery, metastatic cancer, Class III heart failure, inflammatory disorder)
Chronic infections
Obesity with body mass index (BMI) >35
Use of hormone containing medications including steroids or immune modifying drugs
Daily use of analgesics such as opioids;
Daily us of sedative hypnotic medications
Cognitive impairment as evidenced by DSM-5 interview and/or Mini-Mental Status Exam (MMSE < 26)
Actively practicing a mind body intervention.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator: Michael R Irwin, M.D., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Irwin, MD, Principal Investigator, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT03538574

Other Study ID Numbers:

16-001256

First Posted:

May 29, 2018

Last Update Posted:

Mar 19, 2020

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 19, 2020