A Study of Mood and Stress After Spinal Cord Injury | NCT01337908

Studies
A Study of Mood and Stress After Spinal Cord Injury

NCT01337908

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

377Actual

Phase

Not provided

Conditions

Spinal Cord Injury
Depression

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Apr 15, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claire Z. Kalpakjian, Assistant Professor, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

377Actual

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Clara Valley Medical Center		San Jose	California	95128	United States
University of Michigan

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D003863	Depression

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided