Clinical trial NCT03538574: Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers
Official title: Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 139
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-inferiority design
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia clinical response
timeFrame: One-year
Secondary outcomes:
measure: Insomnia clinical response
timeFrame: One year
measure: Daytime dysfunction
timeFrame: One year
measure: Inflammation
timeFrame: One year
measure: Cellular aging
timeFrame: One year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michael R Irwin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: