Mindfulness Based Dementia Care Study

Caregiver Burnout Clinical Trial

Official title:

MBDC-The Mindfulness Based Dementia-Care Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062227
• Other study ID #: A18-306
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Dementia

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