Project VALOR: Veteran Stress and Wellbeing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuity of Military Transition Study: Project VALOR

Conditions
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Alcohol Use Disorder, Depression

Intervention / Treatment
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* Behavioral: Internet Delivered Brief Intervention (IDBI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive an opportunity to engage with a personalized internet-delivered brief intervention (IDBI) and the second group will not be granted access. This IDBI will serve as a second booster intervention for half o those randomized into the treatment condition. For the other half randomized into the treatment condition, this IDBI will serve as an initial intervention coming 12 months after separation from the military.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Condition<br>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)<br>* 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.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heavy Episodic Drinking | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Alcohol-Related Disorders, Alcoholism, Self Medication, Stress Disorders, Post-Traumatic, Depression, Psychological Distress, Drinking Behavior, Substance-Related Disorders