Mindfulness Based Dementia Care Study

MBDC-The Mindfulness Based Dementia-Care Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04062227

Enrollment

Registered

2019-08-20

Start date

2019-01-25

Completion date

2023-03-02

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout

Keywords

Mindfulness, Dementia

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Pre-post Scores on the Perceived Stress Scale (PSS)	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

Measure	Time frame	Description
Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	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

Measure	Time frame	Description
Change in Pre-post Scores on the Zarit Caregiver Burden Scale.	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.
Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE)	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.
Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS)	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.
Change in Pre-post Scores on the Self-Compassion Scale (SCS)	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.
Change in Pre-follow-up Scores on the Resilience Scale	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.
Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale	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.
Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE).	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.
Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	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.
Change in Pre-post Scores on the Resilience Scale	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	26
Total	26

Baseline characteristics

Characteristic	Participants of the MBDC Program
Age, Customized <=18 years	0 Participants
Age, Customized >=65 years	9 Participants
Age, Customized Between 18 and 65 years	13 Participants
Age, Customized No age information	4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	26 Participants
Region of Enrollment United States	26 participants
Sex: Female, Male Female	21 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 26
other Total, other adverse events	0 / 26
serious Total, serious adverse events	0 / 26

Outcome results

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.

Time frame: baseline, 8 weeks

Arm	Measure	Value (MEAN)	Dispersion
Participants of the MBDC Program	Change in Pre-post Scores on the Perceived Stress Scale (PSS)	4.75 score on a scale	Standard Deviation 5.74

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.

Time frame: baseline, 8 weeks

Arm	Measure	Value (MEAN)	Dispersion
Participants of the MBDC Program	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

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

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.