Project VALOR: Veteran Stress and Wellbeing

NCT06095817 | Terminated

• 1 other identifier: Smithers2023
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Alcohol-related problems

  Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

• Change in Suicidal ideation

  Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Other Outcomes (1)

• Change in Employment

  Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

Internet Delivered Brief Intervention (IDBI) BEHAVIORAL

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.

Intervention Condition

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cornell University: lead
• University of Washington: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

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MeSH Terms

Conditions

Alcoholism; Depression; Alcohol-Related Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic; Drinking Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Samuel Bacharach, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: June 1, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)