Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Stress-Busting Program for Caregivers of Patients With Neruological Diseases
This study has been completed.
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122174
  Purpose

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.


Condition Intervention
Psychological Adaptation
Parkinson's Disease
Neurological Disorders
Behavioral: Stress Busting Program for family caregivers

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Caregivers Neurologic Diseases Parkinson's Disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Stress-Busting Program for Caregivers of Patients With Neurological Diseases

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative data resulting from pre and post intervention interviews. [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2004
Study Completion Date: June 2006
Arms Assigned Interventions
1 Behavioral: Stress Busting Program for family caregivers

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122174

Locations
United States, Texas
VA South Texas Health Care System
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Investigators
Principal Investigator: Sharon L. Mantik Lewis, PhD MS BS VA South Texas Health Care System
  More Information

Responsible Party: Department of Veterans Affairs ( Lewis, Sharon - Principal Investigator )
Study ID Numbers: NRI 01-006
Study First Received: July 18, 2005
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00122174  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Caregivers
Stress
Coping
Immune
Relaxation
Biofeedback
Bioinstrumentation
Homecare

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Stress
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009