Project VALOR: Veteran Stress and Wellbeing

Sponsor

Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT06095817

Collaborator

University of Washington (Other)

140

Enrollment

Location

Arms

4.2

Actual Duration (Months)

33.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Depression	Behavioral: Internet Delivered Brief Intervention (IDBI)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Prevention

Official Title:

Continuity of Military Transition Study: Project VALOR

Actual Study Start Date :

Jun 1, 2023

Actual Primary Completion Date :

Oct 6, 2023

Actual Study Completion Date :

Oct 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Condition 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) 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.
No Intervention: Control 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.

Arm

Intervention/Treatment

Experimental: Intervention Condition

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)

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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

Change in Heavy Episodic Drinking [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Change in Modal alcohol consumption [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
Change in Negative Emotional State -- Depression [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
The Patient Health Questionnaire (PHQ)-9

Secondary Outcome Measures

Change in Alcohol-related problems [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
Change in Suicidal ideation [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
Suicide ideation measure developed by Nock, 2007

Other Outcome Measures

Change in Employment [Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army]
Current job situation/Change employment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 62 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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