Linking National Guard Veterans With Need to Mental Health Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01156727
First received: June 22, 2010
Last updated: July 31, 2015
Last verified: July 2015
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Linking National Guard Veterans With Need to Mental Health Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD symptoms [ Time Frame: 6 and 12 months post deployment ] [ Designated as safety issue: No ]
    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.

  • Hazardous alcohol use [ Time Frame: 6 and 12 months post deployment ] [ Designated as safety issue: No ]
    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.

  • Depressive symptoms [ Time Frame: 6 and 12 months post deployment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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."


Secondary Outcome Measures:
  • Mental Health service utilization [ Time Frame: 6 and 12 months post deployment ] [ Designated as safety issue: No ]
    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."


Enrollment: 3015
Study Start Date: July 2010
Study Completion Date: May 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

Michigan Army National Guard soldiers who have returned from OEF/OIF deployments between August 2010 and December 2012.

Exclusion Criteria:

Soldiers who did not return from deployment during the study time period.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156727

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Marcia T. Valenstein, MD AB VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01156727     History of Changes
Other Study ID Numbers: SDP 10-047
Study First Received: June 22, 2010
Last Updated: July 31, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
OEF/OIF
Mental Health
Veterans

ClinicalTrials.gov processed this record on August 27, 2015