Stress-Busting Program for Caregivers of Patients With Neruological Diseases

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00122174

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Adaptation Parkinson's Disease Neurological Disorders	Behavioral: Stress Busting Program for family caregivers	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stress-Busting Program for Caregivers of Patients With Neurological Diseases

Study Start Date :

Jul 1, 2004

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Arm 1

Behavioral: Stress Busting Program for family caregivers

Outcome Measures

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. []