Stress-Busting Program for Caregivers of Patients With Neruological Diseases

April 6, 2015 updated by: US Department of Veterans Affairs

Stress-Busting Program for Caregivers of Patients With Neurological Diseases

Although family caregivers perform an incredibly valuable service for their relatives and the formal health care system, they do so at a considerable cost to themselves both emotionally and physically. Effective stress management techniques can: 1) help to decrease the caregivers' feelings of burden and stress; 2) improve the emotional and physical health of caregivers; and 3) empower caregivers to gain control of their lives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall goal of this randomized clinical trial is to determine the effectiveness of a stress-busting program (SBP) for caregivers of patients with chronic neurological diseases including stroke, Alzheimer's disease, multiple sclerosis, and Parkinson's disease. Specific research objectives include: 1) Prospectively determine the effects of a SBP compared to a standard support group (SSG) on quality of life and immune response in caregivers of patients with chronic neurological diseases. Subjects will be tested at baseline, at completion of 4 and 8 weeks of SBP or SSG, and at 2- and 4-month follow up sessions. 2) Determine subjects' relaxation response as well as their response to acute laboratory stressors using bioinstrumentation. Muscle tension, electrodermal response, skin temperature, blood volume pulse, and heart rate will be measured. Subjects will be tested at baseline, at completion of 4 and 8 weeks of a SBP or SSG, and at 2- and 4-month follow up sessions. 3) Compare the effectiveness of SBP or SSG for adult children caregivers as compared to spousal caregivers based on quality of life measurements, immune parameters, and relaxation response. The proposed multimodal SBP will focus on a variety of approaches based on cognitive behavioral and relaxation response theories. SBP will consist of a 8-week program with 1�-hour sessions per week. The setting will be an educational support group with topics related to stress, stress and challenges of caregiving, depression, coping strategies, positive thinking, and taking time for oneself. In addition, subjects will be taught simple relaxation strategies that they can practice at home. Outcomes will be measured using psychosocial instruments as well as state-of-the science technology including bioinstrumentation and immune parameters to measure biological responses. Follow up testing will be done 2 and 4 months after the end of the SBP or SSG to determine the long-term effectiveness of the intervention.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Health Care System, San Antonio, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The primary caregiver of an individual with a neurological disease. Able to read and converse in English.

Exclusion Criteria:

Presently participating in an ongoing support group related to the neruological disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Behavioral: Stress Busting Program for family caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Questionnaires assessing levels of stress, burden, depression, health, sense of coherence and coping resources; bio-assessment of stress and relaxation, and immune assays. All measures will be taken at baseline, 4 weeks, 8 weeks, 16 weeks, and 32 weeks.

Secondary Outcome Measures

Outcome Measure
Qualitative data resulting from pre and post intervention interviews.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Sharon L. Mantik Lewis, PhD MS BS, South Texas Health Care System, San Antonio, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

July 18, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRI 01-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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