- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01020981
National Guard Outreach and Linkage to Treatment
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Returning MI ARNG member participating in the Buddy-to-Buddy program
Exclusion Criteria:
None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feasibility-response Rate
Prazo: 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.
|
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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Depressive Symptoms
Prazo: 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).
|
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.
|
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
Prazo: 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).
|
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.
|
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).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marcia T. Valenstein, MD AB, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RRP 09-420
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .