NCT04062227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

October 1, 2023

Enrollment Period

4.1 years

First QC Date

August 7, 2019

Results QC Date

February 22, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

MindfulnessDementia

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 8 weeks

Secondary Outcomes (1)

  • Change in Pre-post Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)

    baseline, 8 weeks

Other Outcomes (9)

  • Change in Pre-post Scores on the Self-Compassion Scale (SCS)

    baseline, 8 weeks

  • Change in Pre-post Scores on the Resilience Scale

    baseline, 8 weeks

  • Change in Pre-post Scores on the Zarit Caregiver Burden Scale.

    baseline, 8 weeks

  • +6 more other outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is anyone who is willing and able to attend the MBDC Program.

You may qualify if:

  • Must be ages ≥ 18 years
  • Must be able to read and understand English
  • Participant of the Mindfulness Based Dementia Care (MBDC) Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Caregiver BurdenDementia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Bhavani Kashyap, MBBS, PhD
Organization
HealthPartners Institute

Study Officials

  • Bhavani Kashyap, MBBS, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 20, 2019

Study Start

January 25, 2019

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations