Project VALOR: Veteran Stress and Wellbeing

Depression Clinical Trial

Official title:

Continuity of Military Transition Study: Project VALOR

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06095817
• Other study ID #: Smithers2023
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 6, 2023

Study information

• Verified date: October 2023
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	University of Washington

Country where clinical trial is conducted

United States, 

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Employment	Current job situation/Change employment	Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Primary	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
Primary	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
Primary	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	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
Secondary	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