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The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care (Balance)

Primary Purpose

Dementia, Caregivers, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Caregiver Education & Social Support
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • HealthPartners Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Caregiver Education & Social Support

Arm Description

Behavioral: 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.

Behavioral: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons 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.

Full Information

First Posted
February 1, 2008
Last Updated
September 1, 2023
Sponsor
HealthPartners Institute
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00615082
Brief Title
The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care
Acronym
Balance
Official Title
Stress Reduction for Caregivers: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
We anticipate that caregivers will be interested in participating in the intervention, be open to randomization, and have good rates of compliance with the program. It is also expected that MBSR program participants will evidence a trend toward better outcomes than CESS participants on primary outcome measures of perceived stress, psychological distress and perceived caregiver burden. Substudy The purpose of this proposal is to add a physiologic outcome sub-study to the Balance project that will examine four biological markers correlated with stress in caregivers participating in the study intervention. The Balance Study is a recently funded NIH randomized controlled pilot study to evaluate the acceptability and feasibility of a Mindfulness-Based Stress Reduction (MBSR) intervention for caregivers of patients with dementia. Balance is randomizing caregivers (N=60) into equal numbers to participate in either an intervention arm consisting of a MBSR program that includes eight weeks of group instruction in mindfulness meditation techniques followed by home practice or an active control arm consisting of a standard eight week community Caregiver Education and Social Support (CESS) program. The specific aims of this study are to: 1) evaluate the feasibility of adding physiologic markers to the Balance Study; 2) examine changes over time in individual study participants on four biological markers correlated with stress including interleukin 6 (IL-6), D-dimer, DHEA-S and telomere length; and 3) to examine preliminary differences between MBSR and CESS groups on four biological markers. The addition of physiologic outcomes to the Balance Study presents an emerging opportunity to increase the competitiveness for our NIH R01 application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Caregivers, Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
Behavioral: 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.
Arm Title
Caregiver Education & Social Support
Arm Type
Active Comparator
Arm Description
Behavioral: 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver Education & Social Support
Other Intervention Name(s)
CESS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia.
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Whitebird, PhD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Research Foundation
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care

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