Project VALOR: Veteran Stress and Wellbeing

January 14, 2025 updated by: Cornell University

Continuity of Military Transition Study: Project VALOR

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior veterans as the move into their second year post-Army. Up to 350 veterans drawn from The Network Study (Dept of Defense; Award number: W81XWH1920001) will be recruited with the intention of drawing a final sample of 300. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. The current study examines changes in alcohol/drug use/misuse and depression as veterans transition further into their post-Army environment and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population.

The study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression as veterans move into their second year post-Army; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the veteran population.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

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
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Is US Army veteran who participated in The Network Study (Dept of Defense; Award number: W81XWH1920001)
  • Seeks/engages in civilian employment
  • Lives in US

Exclusion Criteria:

  • Retired with no plans to seek civilian employment
  • Living outside of the US
  • Separated from the National Guard or Reserves

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Condition

Participants assigned to the intervention condition will be invited to engage with an internet-based intervention at the start of the study (12 months following their separation)

  • Half of those in the intervention condition will have already received two prior IDBIs (as part of the DoD funded study) within the first 6 months of separation.
  • The other half of those in the intervention condition will have received no prior IDBIs.
Behavioral: Internet Delivered Brief Intervention (IDBI)
The intervention is an online module that can be accessed through smartphone, tablet, computer or other device. Participants will receive information about alcohol expectancies, alcohol use and norms, identity (service member, veteran, civilian), sleep, stress, and strategies for coping on the job.
No Intervention: Control

The control group will not be offered this month-12 internet-based intervention.

  • Half of those in the control condition will have received two earlier IDBIs (as part of the DoD funded study) within the first 6 months of their separation.
  • The other half of those in the control condition will have received no prior IDBIs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heavy Episodic Drinking
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Modal alcohol consumption
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Negative Emotional State -- Depression
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
The Patient Health Questionnaire (PHQ)-9
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alcohol-related problems
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Suicidal ideation
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Suicide ideation measure developed by Nock, 2007
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Employment
Time Frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Current job situation/Change employment
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Collaborators and Investigators

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

Sponsor

Cornell University

Collaborators

University of Washington

Investigators

  • Principal Investigator: Samuel Bacharach, PhD, Cornell University

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)

June 1, 2023

Primary Completion (Actual)

October 6, 2023

Study Completion (Actual)

October 6, 2023

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Smithers2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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