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Project VALOR: Veteran Stress and Wellbeing

Primary Purpose

Alcohol Use Disorder, Depression

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Delivered Brief Intervention (IDBI)
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use Disorder focused on measuring Alcohol-Related Disorders, Anxiety, Alcoholism, Self Medication, Stress Disorders, Post-Traumatic, Depression, Psychological Distress, Drinking Behavior, Substance-Related Disorders

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Condition

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Heavy Episodic Drinking
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Change in Modal alcohol consumption
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
Change in Negative Emotional State -- Depression
The Patient Health Questionnaire (PHQ)-9

Secondary Outcome Measures

Change in Alcohol-related problems
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
Change in Suicidal ideation
Suicide ideation measure developed by Nock, 2007

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Cornell University
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT06095817
Brief Title
Project VALOR: Veteran Stress and Wellbeing
Official Title
Continuity of Military Transition Study: Project VALOR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding to continue
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 6, 2023 (Actual)
Study Completion Date
October 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cornell University
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Depression
Keywords
Alcohol-Related Disorders, Anxiety, Alcoholism, Self Medication, Stress Disorders, Post-Traumatic, Depression, Psychological Distress, Drinking Behavior, Substance-Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Delivered Brief Intervention (IDBI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heavy Episodic Drinking
Description
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Title
Change in Modal alcohol consumption
Description
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Title
Change in Negative Emotional State -- Depression
Description
The Patient Health Questionnaire (PHQ)-9
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Secondary Outcome Measure Information:
Title
Change in Alcohol-related problems
Description
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Title
Change in Suicidal ideation
Description
Suicide ideation measure developed by Nock, 2007
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Other Pre-specified Outcome Measures:
Title
Change in Employment
Description
Current job situation/Change employment
Time Frame
Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Bacharach, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Project VALOR: Veteran Stress and Wellbeing

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