PTSDNCT01020981
National Guard Outreach and Linkage to Treatment
An observational study of PTSD and Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD, Depression, Reintegration
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MI, IN, and OH ARNG
Who may be able to join
- Returning MI ARNG member participating in the Buddy-to-Buddy program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
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.
Read the 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:
- Prepare for and initiate a formative evaluation of the Buddy*to*Buddy program in the Michigan Army National Guard (MI ARNG).
- 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.
- 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.
- Conditions
- PTSD, Depression, Reintegration, Veterans Health
- Keywords
- OEF/OIF, Peer Group, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008 | |
| Group 2 | Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility-response Rate
Response rate of Soldiers to a mailed survey.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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).
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marcia T. Valenstein, MD AB, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020981
- Sponsor's protocol ID
- RRP 09-420
- Status last verified
- Sep 2014
- First submitted
- 24 Nov 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Valenstein M, Gorman L, Blow AJ, Ganoczy D, Walters H, Kees M, Pfeiffer PN, Kim HM, Lagrou R, Wadsworth SM, Rauch SA, Dalack GW. Reported barriers to mental health care in three samples of U.S. Army National Guard soldiers at three time points. J Trauma Stress. 2014 Aug;27(4):406-14. doi: 10.1002/jts.21942.
PubMed 25158634Burnett-Zeigler I, Valenstein M, Ilgen M, Blow AJ, Gorman LA, Zivin K. Civilian employment among recently returning Afghanistan and Iraq National Guard veterans. Mil Med. 2011 Jun;176(6):639-46. doi: 10.7205/milmed-d-10-00450.
PubMed 21702380Burnett-Zeigler I, Ilgen M, Valenstein M, Zivin K, Gorman L, Blow A, Duffy S, Chermack S. Prevalence and correlates of alcohol misuse among returning Afghanistan and Iraq veterans. Addict Behav. 2011 Aug;36(8):801-6. doi: 10.1016/j.addbeh.2010.12.032. Epub 2011 Jan 13.
PubMed 21482030Dalack GW, Blow AJ, Valenstein M, Gorman L, Spinner J, Marcus S, Kees M, McDonough S, Greden JF, Ames B, Francisco B, Anderson JR, Bartolacci J, Lagrou R. Public-academic partnerships: working together to meet the needs of Army National Guard soldiers: an academic-military partnership. Psychiatr Serv. 2010 Nov;61(11):1069-71. doi: 10.1176/ps.2010.61.11.1069.
PubMed 21041342
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Guard Outreach and Linkage to Treatment
- ClinicalTrials.gov ID
- NCT01020981
- Acronym / sponsor ID
- RRP 09-420
- Conditions
- PTSD, Depression, Reintegration, Veterans Health
- Keywords
- OEF/OIF, Peer Group, Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prepare for and initiate a formative evaluation of the Buddy*to*Buddy program in the Michigan Army National Guard (MI ARNG).
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008 |
| Group 2 | – | –Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MI, IN, and OH ARNG
Key inclusion criteria (1 listed)
- Returning MI ARNG member participating in the Buddy-to-Buddy program
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Response rate of Soldiers to a mailed survey.
2 secondary outcomes
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25158634Valenstein M, Gorman L, Blow AJ, Ganoczy D, Walters H, Kees M, Pfeiffer PN, Kim HM, Lagrou R, Wadsworth SM, Rauch SA, Dalack GW. Reported barriers to mental health care in three samples of U.S. Army National Guard soldiers at three time points. J Trauma Stress. 2014 Aug;27(4):406-14. doi: 10.1002/jts.21942.
- Results publication: PubMed 21702380Burnett-Zeigler I, Valenstein M, Ilgen M, Blow AJ, Gorman LA, Zivin K. Civilian employment among recently returning Afghanistan and Iraq National Guard veterans. Mil Med. 2011 Jun;176(6):639-46. doi: 10.7205/milmed-d-10-00450.
- Results publication: PubMed 21482030Burnett-Zeigler I, Ilgen M, Valenstein M, Zivin K, Gorman L, Blow A, Duffy S, Chermack S. Prevalence and correlates of alcohol misuse among returning Afghanistan and Iraq veterans. Addict Behav. 2011 Aug;36(8):801-6. doi: 10.1016/j.addbeh.2010.12.032. Epub 2011 Jan 13.
- Results publication: PubMed 21041342Dalack GW, Blow AJ, Valenstein M, Gorman L, Spinner J, Marcus S, Kees M, McDonough S, Greden JF, Ames B, Francisco B, Anderson JR, Bartolacci J, Lagrou R. Public-academic partnerships: working together to meet the needs of Army National Guard soldiers: an academic-military partnership. Psychiatr Serv. 2010 Nov;61(11):1069-71. doi: 10.1176/ps.2010.61.11.1069.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia T. Valenstein, MD AB principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Depression, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020981, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.