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A Study of Mood and Stress After Spinal Cord Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337908
First Posted: April 19, 2011
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wayne State University
Santa Clara Valley Health & Hospital System
University of Washington
Information provided by (Responsible Party):
Claire Z. Kalpakjian, University of Michigan
  Purpose
This is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.

Condition
Spinal Cord Injury Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Survey of Vulnerability Factors, Current Stress and Depression Risk in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Claire Z. Kalpakjian, University of Michigan:

Biospecimen Retention:   Samples With DNA
Saliva samples collected with Oragene kit.

Enrollment: 377
Study Start Date: February 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:
The objective of this study is to examine the degree to which vulnerability factors are mediated by stress to increase risk for depression after SCI in a sample of adults who sustained their injuries after the age of 18 years. Participants will complete a written survey (about pain, daily activities, social support and life experiences) and a telephone interview that will provide information about these factors.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women with a traumatic spinal cord injury who are 18 years of age and older
Criteria

Inclusion Criteria:

  • Have a spinal cord injury
  • Were age 16 years or older when injured
  • Sudden onset of symptoms

Exclusion Criteria:

  • Under 19 years old
  • Less than 1 year post-injury
  • had a non-traumatic injury
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337908


Locations
United States, California
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
Rehabilitation Institute of Michigan
Detroit, Michigan, United States, 48201
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Michigan
Wayne State University
Santa Clara Valley Health & Hospital System
University of Washington
  More Information

Responsible Party: Claire Z. Kalpakjian, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01337908     History of Changes
Other Study ID Numbers: H133G070020
First Submitted: April 15, 2011
First Posted: April 19, 2011
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Claire Z. Kalpakjian, University of Michigan:
depression
quality of life
disability

Additional relevant MeSH terms:
Wounds and Injuries
Depression
Depressive Disorder
Spinal Cord Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System