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NCT Number: NCT04062227

Mindfulness Based Dementia Care Study

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.

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Key information

Conditions

Caregiver Burnout Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Pre-post Scores on the Perceived Stress Scale (PSS)

    Time frame: baseline, 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 outcomes

  1. Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: baseline, 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 outcomes

  1. Change in Pre-post Scores on the Self-Compassion Scale (SCS)

    Time frame: baseline, 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 Resilience Scale

    Time frame: baseline, 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.

  3. Change in Pre-post Scores on the Zarit Caregiver Burden Scale.

    Time frame: baseline, 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.

  4. Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE)

    Time frame: baseline, 8 weeks

    The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy.

  5. Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS)

    Time frame: baseline, 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.

  6. Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: baseline, 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.

  7. Change in Pre-follow-up Scores on the Resilience Scale

    Time frame: baseline, 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.

  8. Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale

    Time frame: baseline, 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.

  9. Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE).

    Time frame: baseline, 5 months

    The Brief COPE scores on fourteen subscale scores. Sub-scores are totaled to give a total range [14-112]. Higher scores indicate increased utilization of coping strategy.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

MBDC-The Mindfulness Based Dementia-Care Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2019
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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