A Study of Mood and Stress After Spinal Cord Injury

March 19, 2012 updated by: Claire Z. Kalpakjian, University of Michigan

A Survey of Vulnerability Factors, Current Stress and Depression Risk in Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

377

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Rehabilitation Institute of Michigan
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women with a traumatic spinal cord injury who are 18 years of age and older

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Wayne State University
University of Washington
Santa Clara Valley Health & Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H133G070020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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