National Guard Outreach and Linkage to Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01020981
First received: November 24, 2009
Last updated: April 6, 2015
Last verified: September 2014
Results First Received: November 5, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions: PTSD
Depression
Reintegration
Veterans Health

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Interview and focus group participants and survey pre-testers participated during drill weekends in November and December 2010. Surveys were mailed to MI NG members in March 2011 with 2nd mailing in April 2011, and 3rd mailing in May 2011 and to Indiana NG members with first mailing in Sept 2011 , 2nd in Oct 2011, and 3rd mailing in Nov 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifteen soldiers in Michigan participated in interviews or focus groups during survey development. The survey was fielded to 300 Soldiers, 150 in Michigan and 150 in Indiana. A total of 141 Soldiers either returned a survey and/or completed an interview and were considered enrolled in the study. This is detailed in Participant Flow.

Reporting Groups
  Description
Michigan Army National Guard Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
Indiana Army National Guard Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008

Participant Flow:   Overall Study
    Michigan Army National Guard     Indiana Army National Guard  
STARTED     150     150  
COMPLETED     66     60  
NOT COMPLETED     84     90  
Did not return mailed survey                 74                 58  
Survey returned undeliverable                 8                 32  
Participant declined to complete survey                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Michigan Army National Guard Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
Indiana Army National Guard Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
Total Total of all reporting groups

Baseline Measures
    Michigan Army National Guard     Indiana Army National Guard     Total  
Number of Participants  
[units: participants]
  81     60     141  
Age, Customized  
[units: participants]
     
18-21 yrs     5     0     5  
22-30 yrs     23     9     32  
31-40 yrs     15     8     23  
41-50 yrs     18     28     46  
>50 yrs     3     15     18  
Unknown     17     0     17  
Gender, Customized  
[units: participants]
     
Male     60     46     106  
Female     3     10     13  
Unknown     18     4     22  



  Outcome Measures
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1.  Primary:   Feasibility-response Rate   [ Time Frame: Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011. ]

2.  Secondary:   Depressive Symptoms   [ Time Frame: Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011). ]

3.  Secondary:   PTSD Symptoms   [ Time Frame: Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marcia Valenstein, MD
Organization: VHA HSR&D
phone: 7349453649
e-mail: marcia.valenstein@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01020981     History of Changes
Other Study ID Numbers: RRP 09-420
Study First Received: November 24, 2009
Results First Received: November 5, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government