Linking National Guard Veterans With Need to Mental Health Care
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2010 | ||||
| Last Updated Date | February 13, 2013 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessment and adaptation of the B2B program including assessment of implementation processes, attainment, sustainability, and potential for spread [ Time Frame: First 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01156727 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Linking National Guard Veterans With Need to Mental Health Care | ||||
| Official Title ICMJE | Linking National Guard Veterans With Need to Mental Health Care | ||||
| 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. The study aims are to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications and facilitate future dissemination efforts, 2) assess whether the B2B program increases mental health and substance use treatment initiation and treatment retention among returning National Guard soldiers, and 3) explore whether the B2B program improves mental health symptoms, deceases hazardous alcohol use, and improves soldier well-being. |
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| Detailed Description | The study aims are to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications and facilitate future dissemination efforts, 2) assess whether the B2B program increases mental health and substance use treatment initiation and treatment retention among returning National Guard soldiers, and 3) explore whether the B2B program improves mental health symptoms, deceases hazardous alcohol use, and improves soldier well-being. The study has three components which address each of the three specific aims. The first component will assess B2B implementation using an embedded mixed methods design. This evaluation will include real-time assessment and adaptation of the program, as well as retrospective evaluation of implementation process, sustainability, and potential for spread. The second component will address the impact of B2B on treatment initiation and retention, using an interrupted time series design to assess Michigan National Guard soldiers' VA and non-VA services use in multiple time periods before and after the date of B2B implementation. We will also compare MI ARNG soldiers' services use to that of soldiers in comparison NG Organizations in two contiguous Midwestern states who return from deployment during the same time periods. The third study component will assess the impact of B2B on MI ARNG and comparison NG soldiers' outcomes using longitudinal survey data and adjusting for baseline mental health status using data from the Post Deployment Health Assessment (PDHA). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | MI, IN, and OH ARNG |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 35000 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01156727 | ||||
| Other Study ID Numbers ICMJE | SDP 10-047 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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