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Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers (CARES)

Primary Purpose

Insomnia Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I
MAP-I
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBT-I

MAP-I

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2018
Last Updated
September 30, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03538574
Brief Title
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers
Acronym
CARES
Official Title
Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers: Inflammatory and Biological Aging Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, non-inferiority design
Masking
Care ProviderOutcomes Assessor
Masking Description
Outcome assessor is blind to treatment condition
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Active Comparator
Arm Description
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
Arm Title
MAP-I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-I
Intervention Description
CBT-I is a behavioral treatment for insomnia
Intervention Type
Behavioral
Intervention Name(s)
MAP-I
Intervention Description
MAP-I is a mindfulness meditation treatment for insomnia
Primary Outcome Measure Information:
Title
Insomnia clinical response
Description
Change in severity of insomnia as measured by the Insomnia Severity Index
Time Frame
One-year
Secondary Outcome Measure Information:
Title
Insomnia clinical response
Description
Change in severity of insomnia as measured by clinical diagnosis
Time Frame
One year
Title
Daytime dysfunction
Description
Change in depressed mood as measured by the Inventory of Depressive Symptoms
Time Frame
One year
Title
Inflammation
Description
Change in markers of systemic inflammation as measured by C-reactive protein
Time Frame
One year
Title
Cellular aging
Description
Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Irwin, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

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