Mindfulness Meditation and Insomnia in Alzheimer Disease Caregivers

NCT03538574 | Completed DMC

• 1 other identifier: 16-001256
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• Insomnia clinical response

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

  One-year

Secondary Outcomes (4)

• Insomnia clinical response

  One year

• Daytime dysfunction

  One year

• Inflammation

  One year

• Cellular aging

  One year

Study Arms (2)

CBT-I

ACTIVE COMPARATOR

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

Behavioral: CBT-I

MAP-I

EXPERIMENTAL

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.

Behavioral: MAP-I

Interventions

CBT-I BEHAVIORAL

CBT-I is a behavioral treatment for insomnia

CBT-I

MAP-I BEHAVIORAL

MAP-I is a mindfulness meditation treatment for insomnia

MAP-I

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Michael R Irwin, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor is blind to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, non-inferiority design

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: July 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2021-06

Locations

US (1)