Mindfulness Based Dementia Care Study

August 12, 2024 updated by: HealthPartners Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pre-post Scores on the Perceived Stress Scale (PSS)
Time Frame: 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.
baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 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.
baseline, 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pre-post Scores on the Self-Compassion Scale (SCS)
Time Frame: 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.
baseline, 8 weeks
Change in Pre-post Scores on the Resilience Scale
Time Frame: 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.
baseline, 8 weeks
Change in Pre-post Scores on the Zarit Caregiver Burden Scale.
Time Frame: 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.
baseline, 8 weeks
Change in Pre-post Scores on the Brief Coping Orientation to Problems Experienced (COPE)
Time Frame: 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.
baseline, 8 weeks
Change in Pre-follow-up Scores on the Perceived Stress Scale (PSS)
Time Frame: 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.
baseline, 5 months
Change in Pre-follow-up Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 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.
baseline, 5 months
Change in Pre-follow-up Scores on the Resilience Scale
Time Frame: 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.
baseline, 5 months
Change in Pre-follow-up Scores on the Zarit Caregiver Burden Scale
Time Frame: 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.
baseline, 5 months
Change in Pre-follow-up Scores on the Brief Coping Orientation to Problems Experienced (COPE).
Time Frame: 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.
baseline, 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HealthPartners Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bhavani Kashyap, MBBS, PhD, HealthPartners Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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