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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062227
Other study ID # A18-306
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2019
Est. completion date March 2, 2023

Study information

Verified date October 2023
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States HealthPartners Neuroscience Center Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
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