Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Sponsor
HealthPartners Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05617300
Collaborator
(none)
120
1
1
7.7
15.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the Mindfulness Based Dementia Care (MBDC) program to reduce depressive symptoms in care partners (CPs) of people living with dementia (PLWD).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Dementia Caregiving
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MBDC course

8 week MBDC Course including 8 weekly 2 hour classes and a retreat (4 hours). Individual classes will be held virtually via web-based video calls.

Behavioral: Mindfulness-Based Dementia Caregiving
Mindfulness Based Stress Reduction (MBSR) is a standardized program that is both psychoeducation and skills-based, which uses mindfulness meditation practices to help people better cope with their emotions. This study uses a version of MBSR designed specifically for care partners of people living with dementia (PLWD) called Mindfulness Based Dementia Caregiving. Mindfulness Based Dementia Caregiving (MBDC) is a program with 8 weekly 2 hour sessions (plus one extended practice 4 hour retreat) including both formal and informal mindfulness practices, role play, and lectures combined with some dementia-specific education. Participants learn how to incorporate mindfulness practices into day-to-day life to help cope with the challenges and stresses of dementia care.

Outcome Measures

Primary Outcome Measures

  1. Participation Rate [Baseline]

    Calculation of the participants who attend the first class of their session/the total number of participants who are enrolled. Enrolled is defined as a participant who is assigned to a course. Range [0-1]. A value closer to 1 is indicative of greater feasibility.

  2. Completion Rate [16 weeks]

    Calculation of the participants who completed course/ participants who attend the first class of their session. Completion is defined as attending a minimum of 6 of the 9 classes. Range [0-1]. A value closer to 1 is indicative of greater feasibility.

  3. Questionnaire specific response rate [16 weeks]

    Completeness of questionnaires given over the course of the study. Completeness is defined as answering all questions.

Secondary Outcome Measures

  1. Change in Care Partner Burden [16 weeks]

    Measured using Zarit Burden Interview (ZBI-6). Total of 6 questions scored on a 5 point scale (0-4). The sum of the 6 questions in the total score. Range: 0-24. A higher score is indicative of greater caregiver burden. Change in control period compared to change in intervention period.

  2. Change in Symptoms of Depression [16 weeks]

    Measured using the Center for Epidemiological Studies Depression Scale (CES-D-10). Total of 10 questions scored on a categorical scale (0-3). The sum of the 10 questions is the total score. Range: 0-30. A total value above 10 is considered to be a sign of depression. A higher score represents a greater degree of depressed mood. Change in control period compared to change in intervention period.

Other Outcome Measures

  1. Change in self-compassion [16 weeks]

    Measured using "The State Self-Compassion Scale Short Form." Uses a Likert-type scale ranging from 1 to 5. [Range: 12-60] Higher scores indicates more self compassion.

  2. Change in mindful attention awareness [16 weeks]

    Measured using The 5-Item Mindful Attention Awareness Scale - State This is a 5-item scale to indicate at what level they relate to specific experiences, aimed at measuring main characteristics of mindfulness: (scale is 0-"not at all" to 6-"very much"). [Range: 0-30] Higher scores indicate elevated levels of mindfulness expression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥18 years

  • Self-identify as being an informal CP providing caregiving to a PLWD

  • Register for an MBDC course through the Presence Care Website

Exclusion Criteria:
  • Previous participation in an MBDC program.

  • Does not speak and understand either English or Spanish.

Contacts and Locations

Locations

Site City State Country Postal Code
1 HealthPartners Neuroscience Center Saint Paul Minnesota United States 55130

Sponsors and Collaborators

  • HealthPartners Institute

Investigators

  • Principal Investigator: Leah R Hanson, PhD, HealthPartners Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT05617300
Other Study ID Numbers:
  • A21-117
First Posted:
Nov 15, 2022
Last Update Posted:
Dec 13, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by HealthPartners Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022