CARING: Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Terminated
CT.gov ID
NCT03857308
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Training
  • Behavioral: Reappraisal Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
Actual Study Start Date :
Nov 13, 2019
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness Training

Behavioral: 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

Behavioral: 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:
  • My Time
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Eudaimonic well-being [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.

    2. Change in Sleep Quality [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.

    3. Change in Sleep Quality: Actigraph [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.

    Secondary Outcome Measures

    1. Change in Relationship Quality [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Joseph Dzierzewski, PhD, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT03857308
    Other Study ID Numbers:
    • HM20011802
    First Posted:
    Feb 27, 2019
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Virginia Commonwealth University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 24, 2020