Trial Outcomes & Findings for National Guard Outreach and Linkage to Treatment (NCT NCT01020981)
NCT ID: NCT01020981
Last Updated: 2015-04-28
Results Overview
Response rate of Soldiers to a mailed survey.
COMPLETED
141 participants
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.
2015-04-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
66
|
60
|
|
Overall Study
NOT COMPLETED
|
84
|
90
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Did not return mailed survey
|
74
|
58
|
|
Overall Study
Survey returned undeliverable
|
8
|
32
|
|
Overall Study
Participant declined to complete survey
|
2
|
0
|
Baseline Characteristics
National Guard Outreach and Linkage to Treatment
Baseline characteristics by cohort
| Measure |
Michigan Army National Guard
n=81 Participants
Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
Indiana Army National Guard
n=60 Participants
Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-21 yrs
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Customized
22-30 yrs
|
23 participants
n=5 Participants
|
9 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
31-40 yrs
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Age, Customized
41-50 yrs
|
18 participants
n=5 Participants
|
28 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
>50 yrs
|
3 participants
n=5 Participants
|
15 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
Unknown
|
17 participants
n=5 Participants
|
0 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
60 participants
n=5 Participants
|
46 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 8 or 5% of surveys to Michigan NG Soldiers were not deliverable. 32 (21%) of Indiana NG soldier surveys were not deliverable. 66 of 142 delivered surveys to MI soldiers were returned for a response rate of 46%. 60 of 118 deliverable surveys to Indiana NG Soldiers were returned for a response rate of 51%.
Response rate of Soldiers to a mailed survey.
Outcome measures
| Measure |
Michigan Army National Guard
n=142 Participants
Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
Indiana Army National Guard
n=118 Participants
Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
|---|---|---|
|
Feasibility-response Rate
|
46 % of Soldiers returning mailed survey
|
51 % of Soldiers returning mailed survey
|
SECONDARY outcome
Timeframe: 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).Population: Data were analyzed for those with complete outcome data. Thus, 1 participant in Michigan Army National Guard and 1 participant in Indiana Army National Guard are not included in these results.
The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Michigan Army National Guard
n=65 Participants
Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
Indiana Army National Guard
n=59 Participants
Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
|---|---|---|
|
Depressive Symptoms
|
5.01 units on a BDI-II scale
Standard Deviation 6.02
|
4.81 units on a BDI-II scale
Standard Deviation 5.81
|
SECONDARY outcome
Timeframe: 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).Population: 86% of MI NG soldiers who completed surveys returned a complete PCL scale and 87% of IN NG soldiers who completed surveys returned a complete PCL scale.
The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to "a stressful military experience". Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD.
Outcome measures
| Measure |
Michigan Army National Guard
n=57 Participants
Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
Indiana Army National Guard
n=52 Participants
Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
|
|---|---|---|
|
PTSD Symptoms
|
31.61 units on PCL scale
Standard Deviation 15.88
|
29.56 units on PCL scale
Standard Deviation 15.80
|
Adverse Events
Michigan Army National Guard
Indiana Army National Guard
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place