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National Guard Outreach and Linkage to Treatment

National Guard Outreach and Linkage to Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01020981
Enrollment
141
Registered
2009-11-26
Start date
2010-01-31
Completion date
2011-12-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, PTSD, Reintegration, Veterans Health

Keywords

OEF/OIF, Peer Group, Veterans

Brief summary

This project will add an evaluation/research component to an existing peer outreach program, now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work will be completed in three areas. We will conduct semi-structured interviews with soldiers, Buddies, and National Guard leadership and develop and pilot test survey items relevant to implementation. Further, we will develop and pretest survey items relevant to determining soldier symptomatic and functional status. We will also conduct a small feasibility study, fielding the newly developed survey to a representative sample of recently returned National Guard members from Michigan and Indiana, to determine response rates and veteran willingness to allow access to linkable PDHA/PDHRA data and health services data. Finally, we will construct a merged, de-identified longitudinal dataset comprised of Post-Deployment Health Assessment and Reassessment data, Military Health System/TRICARE, and VA services data from National Guard soldiers in Michigan and comparison states of Indiana and Ohio. This will allow a longitudinal assessment of services initiation and retention for the entire Guard populations in these states.

Detailed description

Background: Soldiers returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) commonly experience symptoms of PTSD, depressive disorders, and interpersonal difficulties. Forty-two percent of National Guard (NG) soldiers report symptoms suggesting a need for evaluation. Unfortunately, only half with mental health needs initiate treatment in the VA or elsewhere. Stigma remains an important barrier. Proactive peer outreach may successfully address stigma and facilitate appropriate treatment use. In the recently implemented Michigan Guard Buddy\*to\*Buddy (B2B) program, all returning MIARNG soldiers are assigned a first-tier Buddy from their unit who systematically telephones them to check in regarding key areas of functioning and symptoms. Soldiers may also be referred to second-tier Buddies, veterans outside the Guard trained in motivational interviewing and supervised by professional staff. The goal of the program is to identify soldiers in need of evaluation and connect them to care in a timely fashion. We will conduct preliminary work that will allow us to assess the need for and the feasibility of adding a rigorous evaluation/research component to the B2B program. Objectives: The goal of this RRP is to assess the need for AND the feasibility of a larger VA study that would use a strong quasi-experimental design (time series analysis with comparison groups) to examine the impact of the B2B program on returning NG veteran mental health treatment initiation, retention, symptoms, and functional outcomes. Specific RRP aims are to: 1. Prepare for and initiate a formative evaluation of the Buddy\*to\*Buddy program in the Michigan Army National Guard (MI ARNG). 2. Develop and determine the feasibility of a confidential surveys for National Guard veterans in Michigan and Indiana that elicit information regarding B2B processes (in MI ARNG), VA outreach processes, mental health symptoms, substance use, and treatment initiation and retention. 3. Construct a de-identified linked dataset consisting of PDHA/PDHRA data, Military Treatment Facility/TRICARE service provider use, and VA service use for MI ARNG and NG soldiers in contiguous states of Indiana and Ohio. Conduct preliminary analyses of these data. Methods: Preliminary work will be completed in two areas. We will begin a formative evaluation of the implementation of the B2B program, using an augmented qualitative RE-AIM Plus framework, multiple data sources and data collection techniques, and conducting field observations and interviews with program stakeholders. Personnel at all levels, including NG leadership, Buddies, and soldiers, will be part of this process. We will also develop and refine survey items relevant to understanding B2B implementation and soldier symptom and functional status. We will test procedures for fielding this survey in Michigan and a comparison state, assessing response rates, and using data to inform the design of a larger study of soldier outcomes.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Returning MI ARNG member participating in the Buddy-to-Buddy program

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Feasibility-response RateSurvey 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.Response rate of Soldiers to a mailed survey.

Secondary

MeasureTime frameDescription
Depressive SymptomsSurvey 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).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.
PTSD SymptomsSurvey 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).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.

Countries

United States

Participant flow

Recruitment details

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

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.

Participants by arm

ArmCount
Michigan Army National Guard
Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
81
Indiana Army National Guard
Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
60
Total141

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not return mailed survey7458
Overall StudyParticipant declined to complete survey20
Overall StudySurvey returned undeliverable832

Baseline characteristics

CharacteristicIndiana Army National GuardMichigan Army National GuardTotal
Age, Customized
18-21 yrs
0 participants5 participants5 participants
Age, Customized
22-30 yrs
9 participants23 participants32 participants
Age, Customized
31-40 yrs
8 participants15 participants23 participants
Age, Customized
41-50 yrs
28 participants18 participants46 participants
Age, Customized
>50 yrs
15 participants3 participants18 participants
Age, Customized
Unknown
0 participants17 participants17 participants
Sex/Gender, Customized
Female
10 participants3 participants13 participants
Sex/Gender, Customized
Male
46 participants60 participants106 participants
Sex/Gender, Customized
Unknown
4 participants18 participants22 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 810 / 60
serious
Total, serious adverse events
0 / 810 / 60

Outcome results

Primary

Feasibility-response Rate

Response rate of Soldiers to a mailed survey.

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.

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%.

ArmMeasureValue (NUMBER)
Michigan Army National GuardFeasibility-response Rate46 % of Soldiers returning mailed survey
Indiana Army National GuardFeasibility-response Rate51 % of Soldiers returning mailed survey
Secondary

Depressive Symptoms

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.

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).

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.

ArmMeasureValue (MEAN)Dispersion
Michigan Army National GuardDepressive Symptoms5.01 units on a BDI-II scaleStandard Deviation 6.02
Indiana Army National GuardDepressive Symptoms4.81 units on a BDI-II scaleStandard Deviation 5.81
Secondary

PTSD Symptoms

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.

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).

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.

ArmMeasureValue (MEAN)Dispersion
Michigan Army National GuardPTSD Symptoms31.61 units on PCL scaleStandard Deviation 15.88
Indiana Army National GuardPTSD Symptoms29.56 units on PCL scaleStandard Deviation 15.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026