Clinical trial NCT06095817: Project VALOR: Veteran Stress and Wellbeing
Official title: Continuity of Military Transition Study: Project VALOR
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Use Disorder
Depression
Keywords: Alcohol-Related Disorders
Anxiety
Alcoholism
Self Medication
Stress Disorders, Post-Traumatic
Depression
Psychological Distress
Drinking Behavior
Substance-Related Disorders
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2023-10-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Heavy Episodic Drinking
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
measure: Change in Modal alcohol consumption
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
measure: Change in Negative Emotional State -- Depression
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Secondary outcomes:
measure: Change in Alcohol-related problems
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
measure: Change in Suicidal ideation
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Other outcomes:
measure: Change in Employment
timeFrame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Cornell University
name: Samuel Bacharach, PhD
role: PRINCIPAL_INVESTIGATOR
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