Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122174
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-07-18
Brief Title:
Stress-Busting Program for Caregivers of Patients With Neruological Diseases
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Stress-Busting Program for Caregivers of Patients With Neurological Diseases
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Alzheimers disease multiple sclerosis and Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None