Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers



Status:Recruiting
Conditions:Alzheimer Disease, Insomnia Sleep Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:45 - 95
Updated:9/8/2018
Start Date:July 1, 2018
End Date:May 30, 2024
Contact:Michael Irwin, M.D.
Email:mirwin1@ucla.edu
Phone:310 825 8281

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.
We found this trial at
1
site
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California 90095
Principal Investigator: Michael R. Irwin, MD
Phone: 310-825-8281
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mi
from
Los Angeles, CA
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