NCT00122174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 7, 2015

Status Verified

January 1, 2007

First QC Date

July 18, 2005

Last Update Submit

April 6, 2015

Conditions

Psychological AdaptationParkinson's DiseaseNeurological Disorders

Keywords

CaregiversStressCopingImmuneRelaxationBiofeedbackBioinstrumentationHomecare

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Qualitative data resulting from pre and post intervention interviews.

Study Arms (1)

Arm 1

OTHER
Behavioral: Stress Busting Program for family caregivers

Interventions

Stress Busting Program for family caregiversBEHAVIORAL
Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseNervous System Diseases

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Sharon L. Mantik Lewis, PhD MS BS

    South Texas Health Care System, San Antonio, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

July 1, 2004

Study Completion

June 1, 2006

Last Updated

April 7, 2015

Record last verified: 2007-01

Locations

US(1)