Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia (CARING)
Primary Purpose
Caregivers, Burnout, Sleep
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Reappraisal Training
Sponsored by
About this trial
This is an interventional treatment trial for Caregivers focused on measuring well-being, sleep, caregiver
Eligibility Criteria
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Training
Reappraisal Training
Arm Description
Outcomes
Primary Outcome Measures
Change in Eudaimonic well-being
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.
Change in Sleep Quality
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.
Change in Sleep Quality: Actigraph
Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
Secondary Outcome Measures
Change in Relationship Quality
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.
Full Information
NCT ID
NCT03857308
First Posted
January 7, 2019
Last Updated
April 22, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03857308
Brief Title
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
Acronym
CARING
Official Title
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to continue enrollment for dissertation study due to COVID-19
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.
Detailed Description
The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Burnout, Sleep
Keywords
well-being, sleep, caregiver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Title
Reappraisal Training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reappraisal Training
Other Intervention Name(s)
My Time
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Eudaimonic well-being
Description
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.
Time Frame
Baseline to 2-weeks (post-intervention), and 3-month follow-up
Title
Change in Sleep Quality
Description
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.
Time Frame
Baseline to 2-weeks (post-intervention), and 3-month follow-up
Title
Change in Sleep Quality: Actigraph
Description
Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
Time Frame
Baseline to 2-weeks (post-intervention), and 3-month follow-up
Secondary Outcome Measure Information:
Title
Change in Relationship Quality
Description
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.
Time Frame
Baseline to 2-weeks (post-intervention), and 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Dzierzewski, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
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