Summary

for people ages 45-95 (full criteria)
at UCLA
study started
estimated completion
Michael R Irwin, M.D. (ucla)

Description

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

Official Title

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

Details

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.

Keywords

Insomnia Chronic Alzheimer Disease Sleep Initiation and Maintenance Disorders CBT-I MAP-I

Eligibility

You can join if…

Open to people ages 45-95

  • 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

You CAN'T join if...

  • 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.

Location

  • Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute accepting new patients
    Los Angeles California 90095 United States

Lead Scientist

  • Michael R Irwin, M.D. (ucla)
    Professor, Psychiatry and Biobehavioral Sciences. Authored (or co-authored) 251 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT03538574
Study Type
Interventional
Last Updated