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OpenTrials
Completed

NCT Number: NCT03538574

Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

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

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

45 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-I

Behavioral

CBT-I is a behavioral treatment for insomnia

MAP-I

Behavioral

MAP-I is a mindfulness meditation treatment for insomnia

Primary outcomes

  1. Insomnia clinical response

    Time frame: One-year

    Change in severity of insomnia as measured by the Insomnia Severity Index

Secondary outcomes

  1. Insomnia clinical response

    Time frame: One year

    Change in severity of insomnia as measured by clinical diagnosis

  2. Daytime dysfunction

    Time frame: One year

    Change in depressed mood as measured by the Inventory of Depressive Symptoms

  3. Inflammation

    Time frame: One year

    Change in markers of systemic inflammation as measured by C-reactive protein

  4. Cellular aging

    Time frame: One year

    Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Acronym: CARES

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 29, 2018
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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