Linking National Guard Veterans With Need to Mental Health Care

June 2, 2017 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3015

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and 12 months post deployment
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.
6 and 12 months post deployment
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.
6 and 12 months post deployment
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."
6 and 12 months post deployment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health service utilization
Time Frame: 6 and 12 months post deployment
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."
6 and 12 months post deployment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Marcia T. Valenstein, MD AB, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

January 31, 2014

Study Completion (Actual)

May 30, 2014

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDP 10-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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