Mindfulness Based Dementia Care Study

Sponsor
HealthPartners Institute (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04062227
Collaborator
(none)
50
1
47.2
1.1

Study Details

Study Description

Brief Summary

Mindfulness based stress reduction (MBSR) refers to a particular type of attention focused on the present moment, non-judgmental awareness, and acceptance of that experience with openness and curiosity. Mindfulness training was designed to enhance the range and use of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in maladaptive ways 1-3. Investigators are evaluating a new program, called the Mindfulness Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the traditional approaches with education. The overall objective of this study is to evaluate the program and explore the potential benefits of the Mindfulness Based Dementia-Care (MBDC) program. Investigators are conducting a prospective, pre-post, observational study with members participating in the MBDC program.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MBDC-The Mindfulness Based Dementia-Care Study
    Actual Study Start Date :
    Jan 25, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Change in pre-post scores on the Perceived Stress Scale (PSS) [8 weeks]

      The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress.

    Secondary Outcome Measures

    1. Change in pre-post scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [8 weeks]

      The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms.

    Other Outcome Measures

    1. Change in pre-post scores on the Self-Compassion Scale (SCS) [8 weeks]

      The SCS scores on a mean score. The range of the SCS is 1-5 points. A higher score is indicative higher self-compassion.

    2. Change in pre-post scores on the Medical Outcomes Study (MOS) Sleep Scale [8 weeks]

      The MOS Sleep Scale scores on a total score. The range of the scale is 0-100 points. A higher score is indicative higher sleep disturbance.

    3. Change in pre-post scores on the Resilience Scale [8 weeks]

      The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience.

    4. Change in pre-post scores on the Zarit Caregiver Burden Scale. [8 weeks]

      The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden.

    5. Change in pre-post scores on the Brief Coping Orientation to Problems Experienced (COPE) [8 weeks]

      The Brief COPE scores on fourteen subscale mean scores. The range of the Brief COPE range is 0-7 points for each subscale. Higher scores indicate increased utilization of that specific coping strategy.

    6. Change in pre-follow-up scores on the Perceived Stress Scale (PSS) [5 months]

      The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress.

    7. Change in pre-follow-up scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [5 months]

      The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms.

    8. Change in pre-follow-up scores on the Medical Outcomes Study (MOS) Sleep Scale [5 months]

      The MOS Sleep Scale scores on a total score. The range of the scale is 0-100 points. A higher score is indicative higher sleep disturbance.

    9. Change in pre-follow-up scores on the Resilience Scale [5 months]

      The Resilience Scale scores on a total score. The range of The Resilience Scale is 14-98 points. A higher score is indicative of higher resilience.

    10. Change in pre-follow-up scores on the Zarit Caregiver Burden Scale [5 months]

      The Zarit Caregiver Burden Scale scores on a total score. The range of the Zarit range is 0-88 points. A higher score is indicative of the presence of a higher level of caregiver burden.

    11. Change in pre-follow-up scores on the Brief Coping Orientation to Problems Experienced (COPE). [5 months]

      The Brief COPE scores on fourteen subscale mean scores. The range of the Brief COPE range is 0-7 points for each subscale. Higher scores indicate increased utilization of that specific coping strategy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Must be ages ≥ 18 years

    • Must be able to read and understand English

    • Participant of the Mindfulness Based Dementia Care (MBDC) Program

    Exclusion Criteria:
    • There is no exclusion criteria for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HealthPartners Neuroscience Center Saint Paul Minnesota United States 55130

    Sponsors and Collaborators

    • HealthPartners Institute

    Investigators

    • Principal Investigator: Bhavani Kashyap, MBBS, PhD, HealthPartners Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HealthPartners Institute
    ClinicalTrials.gov Identifier:
    NCT04062227
    Other Study ID Numbers:
    • A18-306
    First Posted:
    Aug 20, 2019
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HealthPartners Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 28, 2021