Insomnia Chronic
Conditions
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.
Interventions
BEHAVIORALCBT-I
CBT-I is a behavioral treatment for insomnia
BEHAVIORALMAP-I
MAP-I is a mindfulness meditation treatment for insomnia
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Outcome assessor is blind to treatment condition
Intervention model description
Randomized, non-inferiority design
Eligibility
Sex/Gender
ALL
Age
45 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia clinical response | One-year | Change in severity of insomnia as measured by the Insomnia Severity Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia clinical response | One year | Change in severity of insomnia as measured by clinical diagnosis |
| Daytime dysfunction | One year | Change in depressed mood as measured by the Inventory of Depressive Symptoms |
| Inflammation | One year | Change in markers of systemic inflammation as measured by C-reactive protein |
| Cellular aging | One year | Change in markers of cellular aging as measured by transcriptional profiles of the senescent secretory associated phenotype (SASP) |
Countries
United States
Outcome results
None listed