Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

Insomnia Chronic Clinical Trial

— CARES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538574
• Other study ID #: 16-001256
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBT-I
CBT-I is a behavioral treatment for insomnia
• MAP-I
MAP-I is a mindfulness meditation treatment for insomnia

Locations

Country	Name	City	State
United States	Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia clinical response	Change in severity of insomnia as measured by the Insomnia Severity Index	One-year
Secondary	Insomnia clinical response	Change in severity of insomnia as measured by clinical diagnosis	One year
Secondary	Daytime dysfunction	Change in depressed mood as measured by the Inventory of Depressive Symptoms	One year
Secondary	Inflammation	Change in markers of systemic inflammation as measured by C-reactive protein	One year
Secondary	Cellular aging	Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP)	One year