Mindfulness Based Dementia Care Study

MBDC-The 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.

Study Overview

• Status: Completed
• Conditions: Caregiver Burnout

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population is anyone who is willing and able to attend the MBDC Program.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre-post scores on the Perceived Stress Scale (PSS)	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre-post scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	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 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pre-post scores on the Self-Compassion Scale (SCS)	The SCS scores on a mean score. The range of the SCS is 1-5 points. A higher score is indicative higher self-compassion.	8 weeks
Change in pre-post scores on the Medical Outcomes Study (MOS) Sleep Scale	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.	8 weeks
Change in pre-post scores on the Resilience Scale	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 weeks
Change in pre-post scores on the Zarit Caregiver Burden Scale.	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.	8 weeks
Change in pre-post scores on the Brief Coping Orientation to Problems Experienced (COPE)	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.	8 weeks
Change in pre-follow-up scores on the Perceived Stress Scale (PSS)	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.	5 months
Change in pre-follow-up scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	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.	5 months
Change in pre-follow-up scores on the Medical Outcomes Study (MOS) Sleep Scale	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.	5 months
Change in pre-follow-up scores on the Resilience Scale	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.	5 months
Change in pre-follow-up scores on the Zarit Caregiver Burden Scale	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 months
Change in pre-follow-up scores on the Brief Coping Orientation to Problems Experienced (COPE).	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.	5 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Dementia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stress, Psychological; Dementia; Caregiver Burden
• Other Study ID Numbers: A18-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No