HealthyNCT01156727
Linking National Guard Veterans With Need to Mental Health Care
An observational study of Healthy, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project added an evaluation/research component to an existing peer outreach program, implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were to: 1) evaluate the implementation of the B2B program to inform ongoing program modifications and facilitate future dissemination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- How many people
- 3,015 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 30 May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: SURVEY: Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012. INTERVIEW: Michigan Army National Guard soldiers and key B2B stakeholders.
Who may be able to join
- Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012.
Who cannot join
- Soldiers who did not return from deployment during the study time period.
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 added an evaluation/research component to an existing peer outreach program, implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were 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.
Read the detailed description
The study aims were 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 had three components which addressed each of the three specific aims. The first component assessed B2B implementation using an embedded mixed methods design. This evaluation included real-time assessment and adaptation of the program, as well as retrospective evaluation of implementation process, sustainability, and potential for spread. The second component addressed the impact of B2B on treatment initiation and retention. Preliminary analyses were completed using regression analyses. Pending additional data from the DoD, 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 will be conducted.. The third study component assessed the impact of B2B on MI ARNG soldiers' outcomes using longitudinal survey data and adjusting for baseline mental health status using data from the Post Deployment Health Assessment (PDHA).
- Conditions
- Healthy
- Keywords
- OEF/OIF, Mental Health, Veterans
- Medical subject headings
- Psychological Well-Being
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 |
|---|---|---|
| SURVEY: 6 months post-deployment | Michigan Army National Guard soldiers 6 months post deployment between August 2011 and December 2013 | |
| SURVEY: 12 months post-deployment | Michigan Army National Guard soldiers 12 months post deployment between August 2011 and December 2013. | |
| INTERVIEWS | Michigan Army National Guard soldiers 12-24 months post deployment between October 2011-April 2014. Also key stakeholders from the B2B program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazardous alcohol use
Hazardous alcohol use was assessed using the AUDIT-C, a 3-item alcohol screen for hazardous drinking and active alcohol use disorders (including alcohol abuse or dependence). In men, a score of 4 or more is considered positive, and in women, a score of 3 or more is considered positive.
Measured: 6 and 12 months post deployment
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: 6 and 12 months post deployment
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: 6 and 12 months post deployment
Awareness of B2B Program
National Guard soldiers were considered to be aware of the B2B program if they endorsed a survey item asking about awareness of the B2B program in the MIARNG. The question was, "I am aware that the MI ARNG has a B2B program," with response items of "No" and "Yes."
Measured: 6 and 12 months post deployment
Secondary outcomes (1)
Mental Health service utilization
National Guard soldiers were considered to have received mental health services if they endorsed any of 14 survey items asking about the receipt of mental health services for a stress, emotional, alcohol, or family problem from either general medical or mental health providers in a variety of settings (military, civilian, VA clinics, or in vet centers) in the last year. The question format used was "In the past, have you received mental health services for a stress, emotional, or family problem from: [specified provider] with response items of "No," "Yes, in the last year," or "Yes, but more than a year ago."
Measured: 6 and 12 months post deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study start1 Jul 2010
- Primary completion31 Jan 2014
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 3,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- 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
- NCT01156727
- Sponsor's protocol ID
- SDP 10-047
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2010
- Last updated
- 6 Jun 2017
- Results posted
- No
- 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 25158634Bonar EE, Bohnert KM, Walters HM, Ganoczy D, Valenstein M. Student and Nonstudent National Guard Service Members/Veterans and Their Use of Services for Mental Health Symptoms. J Am Coll Health. 2015;63(7):437-46. doi: 10.1080/07448481.2014.975718.
PubMed 25337770Sripada RK, Richards SK, Rauch SA, Walters HM, Ganoczy D, Bohnert KM, Gorman LA, Kees M, Blow AJ, Valenstein M. Socioeconomic Status and Mental Health Service Use Among National Guard Soldiers. Psychiatr Serv. 2015 Sep;66(9):992-5. doi: 10.1176/appi.ps.201400346. Epub 2015 May 1.
PubMed 25930042Sripada RK, Bohnert AS, Teo AR, Levine DS, Pfeiffer PN, Bowersox NW, Mizruchi MS, Chermack ST, Ganoczy D, Walters H, Valenstein M. Social networks, mental health problems, and mental health service utilization in OEF/OIF National Guard veterans. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1367-78. doi: 10.1007/s00127-015-1078-2. Epub 2015 Jun 2.
PubMed 26032182Nelson CB, Zivin K, Walters H, Ganoczy D, MacDermid Wadsworth S, Valenstein M. Factors Associated With Civilian Employment, Work Satisfaction, and Performance Among National Guard Members. Psychiatr Serv. 2015 Dec 1;66(12):1318-25. doi: 10.1176/appi.ps.201400334. Epub 2015 Aug 17.
PubMed 26278223Gorman LA, Sripada RK, Ganoczy D, Walters HM, Bohnert KM, Dalack GW, Valenstein M. Determinants of National Guard Mental Health Service Utilization in VA versus Non-VA Settings. Health Serv Res. 2016 Oct;51(5):1814-37. doi: 10.1111/1475-6773.12446. Epub 2016 Feb 3.
PubMed 26840993Zivin K, Yosef M, Levine DS, Abraham KM, Miller EM, Henry J, Nelson CB, Pfeiffer PN, Sripada RK, Harrod M, Valenstein M. Employment status, employment functioning, and barriers to employment among VA primary care patients. J Affect Disord. 2016 Mar 15;193:194-202. doi: 10.1016/j.jad.2015.12.054. Epub 2015 Dec 30.
PubMed 26773911Kim HM, Levine DS, Pfeiffer PN, Blow AJ, Marchiondo C, Walters H, Valenstein M. Postdeployment Suicide Risk Increases Over a 6-month Period: Predictors of Increased Risk among Midwestern Army National Guard Soldiers. Suicide Life Threat Behav. 2017 Aug;47(4):421-435. doi: 10.1111/sltb.12303. Epub 2016 Oct 5.
PubMed 27704587
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking National Guard Veterans With Need to Mental Health Care
- ClinicalTrials.gov ID
- NCT01156727
- Acronym / sponsor ID
- SDP 10-047
- Conditions
- Healthy
- Keywords
- OEF/OIF, Mental Health, Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,015 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project added an evaluation/research component to an existing peer outreach program, implemented for over 1100 soldiers in the Michigan Army National Guard. The study aims were 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.
Detailed description
The study aims were 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 had three components which addressed each of the three specific aims. The first component assessed B2B implementation using an embedded mixed methods design. This evaluation included real-time assessment and adaptation of the program, as well as retrospective evaluation of implementation process, sustainability, and potential for spread. The second component addressed the impact of B2B on treatment initiation and retention. Preliminary analyses were completed using regression analyses. Pending additional data from the DoD, 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 will be conducted.. The third study component assessed the impact of B2B on MI ARNG soldiers' outcomes using longitudinal survey data and adjusting for baseline mental health status using data from the Post Deployment Health Assessment (PDHA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SURVEY: 6 months post-deployment | – | –Michigan Army National Guard soldiers 6 months post deployment between August 2011 and December 2013 |
| SURVEY: 12 months post-deployment | – | –Michigan Army National Guard soldiers 12 months post deployment between August 2011 and December 2013. |
| INTERVIEWS | – | –Michigan Army National Guard soldiers 12-24 months post deployment between October 2011-April 2014. Also key stakeholders from the B2B program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SURVEY: Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012. INTERVIEW: Michigan Army National Guard soldiers and key B2B stakeholders.
Key inclusion criteria (1 listed)
- Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012.
Key exclusion criteria (1 listed)
- Soldiers who did not return from deployment during the study time period.
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
Hazardous alcohol use
Time frame: 6 and 12 months post deployment
Hazardous alcohol use was assessed using the AUDIT-C, a 3-item alcohol screen for hazardous drinking and active alcohol use disorders (including alcohol abuse or dependence). In men, a score of 4 or more is considered positive, and in women, a score of 3 or more is considered positive.
PTSD symptoms
Time frame: 6 and 12 months post deployment
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.
Depressive symptoms
Time frame: 6 and 12 months post deployment
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.
Awareness of B2B Program
Time frame: 6 and 12 months post deployment
National Guard soldiers were considered to be aware of the B2B program if they endorsed a survey item asking about awareness of the B2B program in the MIARNG. The question was, "I am aware that the MI ARNG has a B2B program," with response items of "No" and "Yes."
1 secondary outcome
Mental Health service utilization
Time frame: 6 and 12 months post deployment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- 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 25337770Bonar EE, Bohnert KM, Walters HM, Ganoczy D, Valenstein M. Student and Nonstudent National Guard Service Members/Veterans and Their Use of Services for Mental Health Symptoms. J Am Coll Health. 2015;63(7):437-46. doi: 10.1080/07448481.2014.975718.
- Results publication: PubMed 25930042Sripada RK, Richards SK, Rauch SA, Walters HM, Ganoczy D, Bohnert KM, Gorman LA, Kees M, Blow AJ, Valenstein M. Socioeconomic Status and Mental Health Service Use Among National Guard Soldiers. Psychiatr Serv. 2015 Sep;66(9):992-5. doi: 10.1176/appi.ps.201400346. Epub 2015 May 1.
- Results publication: PubMed 26032182Sripada RK, Bohnert AS, Teo AR, Levine DS, Pfeiffer PN, Bowersox NW, Mizruchi MS, Chermack ST, Ganoczy D, Walters H, Valenstein M. Social networks, mental health problems, and mental health service utilization in OEF/OIF National Guard veterans. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1367-78. doi: 10.1007/s00127-015-1078-2. Epub 2015 Jun 2.
- Results publication: PubMed 26278223Nelson CB, Zivin K, Walters H, Ganoczy D, MacDermid Wadsworth S, Valenstein M. Factors Associated With Civilian Employment, Work Satisfaction, and Performance Among National Guard Members. Psychiatr Serv. 2015 Dec 1;66(12):1318-25. doi: 10.1176/appi.ps.201400334. Epub 2015 Aug 17.
- Results publication: PubMed 26840993Gorman LA, Sripada RK, Ganoczy D, Walters HM, Bohnert KM, Dalack GW, Valenstein M. Determinants of National Guard Mental Health Service Utilization in VA versus Non-VA Settings. Health Serv Res. 2016 Oct;51(5):1814-37. doi: 10.1111/1475-6773.12446. Epub 2016 Feb 3.
- Results publication: PubMed 26773911Zivin K, Yosef M, Levine DS, Abraham KM, Miller EM, Henry J, Nelson CB, Pfeiffer PN, Sripada RK, Harrod M, Valenstein M. Employment status, employment functioning, and barriers to employment among VA primary care patients. J Affect Disord. 2016 Mar 15;193:194-202. doi: 10.1016/j.jad.2015.12.054. Epub 2015 Dec 30.
- Results publication: PubMed 27704587Kim HM, Levine DS, Pfeiffer PN, Blow AJ, Marchiondo C, Walters H, Valenstein M. Postdeployment Suicide Risk Increases Over a 6-month Period: Predictors of Increased Risk among Midwestern Army National Guard Soldiers. Suicide Life Threat Behav. 2017 Aug;47(4):421-435. doi: 10.1111/sltb.12303. Epub 2016 Oct 5.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Healthy, run by VA Office of Research and Development 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 6 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hazardous alcohol use (time frame: 6 and 12 months post deployment). The study lists 4 primary outcomes in all. 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 NCT01156727, which also lists 8 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 6 Jun 2017.