The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care
Balance
Stress Reduction for Caregivers: A Randomized Controlled Pilot Study
2 other identifiers
interventional
78
1 country
1
Brief Summary
The primary goals of this exploratory/developmental (R21) study are to evaluate the feasibility and acceptability of a MBSR intervention for caregivers of patients with dementia, and to estimate the effectiveness of program outcomes on standardized measures of perceived stress, psychological distress and caregiver burden. We will randomize 60 caregivers 1:1 to participate in: 1.) an intervention arm consisting of a MBSR program that includes 8 weeks of group instruction in mindfulness meditation techniques followed by home practice, or 2.) an active control arm consisting of a standard 8 week Community Caregiver Education and Support (CESS) program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedSeptember 7, 2023
September 1, 2011
2.2 years
February 1, 2008
September 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the feasibility of conducting a trial comparing mindfulness-based stress reduction (MBSR) and community caregiver education and support (CESS) programs on stress reduction for caregivers of patients with dementia.
participants will complete surveys and consent to a blood draw at baseline, post intervention, and 6 months. They will complete a daily health behaviors calendar, and a subset will track their daily blood pressure.
through study completion, an average of 1 year
Secondary Outcomes (1)
Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia.
through study completion, an average of 1 year
Study Arms (2)
Mindfulness-Based Stress Reduction
EXPERIMENTALBehavioral: Mindfulness-Based Stress Reduction Other Names: MBSR An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
Caregiver Education & Social Support
ACTIVE COMPARATORBehavioral: Caregiver Education \& Social Support Other Names: CESS An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
Interventions
An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
Eligibility Criteria
You may qualify if:
- adult, 21 or older
- caregiver for a community dwelling patient with dementia
- English speaking
- literate - able to read course materials
- mentally intact with no history of mental illness
- reachable by phone
- able to attend weekly classes in the Bloomington area
- interested in either type of program (psycho-educational/mind-body intervention)
- willing to complete an informed consent process
- willing to be randomized and participate in one of two interventions
- experiencing significant stress (scale of 1-10 score of 5 or higher)
You may not qualify if:
- have previously participated in a community caregiver education and support group
- have previously completed formal training in other mind body practices such as meditation, yoga, or tai chi, or who are currently practicing
- are regularly practicing mindfulness meditation
- express uncertainty that they can attend the intervention on a regular basis
- not experiencing significant stress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HealthPartners Research Foundation
Bloomington, Minnesota, 55425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Whitebird, PhD
HealthPartners Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
February 1, 2007
Primary Completion
May 1, 2009
Study Completion
March 1, 2011
Last Updated
September 7, 2023
Record last verified: 2011-09