- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03857308
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia (CARING)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking
- Self-reporting informal caregivers of persons with dementia
Exclusion Criteria:
- Self-reported major depressive disorder with psychotic features
- History of schizophrenia
- Bipolar disorder
- Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
- Previous MBSR training or regular meditative practice within previous 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness Training
|
This stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to "mentally welcome" all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training. A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete. |
Active Comparator: Reappraisal Training
|
This stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in "Coping control." Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change. A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Eudaimonic well-being
Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff & Keyes, 1995) 1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being. |
Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
Change in Sleep Quality
Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
We will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency.
This will allow us to understand any changes in overall sleep quality across the intervention.
|
Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
Change in Sleep Quality: Actigraph
Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
|
Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Relationship Quality
Time Frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
The Mutuality Scale of Family Care Inventory (Archbold, Stewart, Greenlick, & Harvath, 1990) will be used to assess for change in caregiver/care recipient relationship quality.
It is a 15-item self-report measure to assess caregiver's perceived relationship quality with the care recipient.
The scale items range in score from 1 to 4, with higher scores indicating greater relationship quality.
Items are summed to create a total score.
|
Baseline to 2-weeks (post-intervention), and 3-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Dzierzewski, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20011802
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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