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

HealthPartners Institute

Status: Completed

Conditions: Dementia; Stress; Caregivers

Treatments: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Caregiver Education & Social Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00615082

1R21AT003654-01A1

R21AT003654-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Experimental group

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Caregiver Education & Social Support

Active Comparator group

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.

Treatment:

Behavioral: Caregiver Education & Social Support