Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Dementia Clinical Trial

Official title:

Mindfulness-based Dementia Care Partner Program to Reduce Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617300
• Other study ID #: A21-117
• Status: Completed
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: December 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 20, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in self-compassion	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.	16 weeks
Other	Change in mindful attention awareness	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.	16 weeks
Primary	Participation Rate	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.	Baseline
Primary	Completion Rate	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.	16 weeks
Primary	Questionnaire specific response rate	Completeness of questionnaires given over the course of the study. Completeness is defined as answering all questions.	16 weeks
Secondary	Change in Care Partner Burden	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.	16 weeks
Secondary	Change in Symptoms of Depression	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.	16 weeks