- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01020981
National Guard Outreach and Linkage to Treatment
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Returning MI ARNG member participating in the Buddy-to-Buddy program
Exclusion Criteria:
None
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Group 1
Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
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Group 2
Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Feasibility-response Rate
Lasso di tempo: 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.
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Response rate of Soldiers to a mailed survey.
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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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Depressive Symptoms
Lasso di tempo: 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).
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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.
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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).
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PTSD Symptoms
Lasso di tempo: 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).
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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.
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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).
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Marcia T. Valenstein, MD AB, VA Ann Arbor Healthcare System, Ann Arbor, MI
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Burnett-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.
- Burnett-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.
- Dalack 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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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RRP 09-420
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