Trial Outcomes & Findings for Mindfulness Based Dementia Care Study (NCT NCT04062227)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

26 participants

Primary outcome timeframe

baseline, 8 weeks

Results posted on

2024-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Participants of the MBDC Program Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Overall Study STARTED	26
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness Based Dementia Care Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants of the MBDC Program n=26 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Age, Customized <=18 years	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	13 Participants n=5 Participants
Age, Customized >=65 years	9 Participants n=5 Participants
Age, Customized No age information	4 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Perceived Stress Scale (PSS)	4.75 score on a scale Standard Deviation 5.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	6.25 score on a scale Standard Deviation 7.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Self-Compassion Scale (SCS)	-0.4 score on a scale Standard Deviation 0.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Resilience Scale	0.25 score on a scale Standard Deviation 13.34

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Zarit Caregiver Burden Scale.	2.00 score on a scale Standard Deviation 6.50

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=20 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE)	-0.60 score on a scale Standard Deviation 1.11

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=11 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS)	2.82 score on a scale Standard Deviation 6.79

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=11 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	5.91 score on a scale Standard Deviation 7.35

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=11 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-follow-up Scores on the Resilience Scale	-4.82 score on a scale Standard Deviation 8.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=11 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale	3.00 score on a scale Standard Deviation 3.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants of the MBDC Program n=11 Participants Mindfulness Based Dementia Care (MBDC) program is an 8 week program for caregivers (CG) of people living with dementia, which combines traditional mindfulness based stress reduction approaches with education.
Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE).	-0.64 score on a scale Standard Deviation 1.30

Adverse Events

Participants of the MBDC Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bhavani Kashyap, MBBS, PhD

HealthPartners Institute

Phone: 651-495-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place