- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463225
The Network Study: Soldiers Connecting for Work and Health
Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition
Study Overview
Status
Conditions
Intervention / Treatment
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 soldiers undergo the transition from Active Duty to Veteran 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 over the transition; 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 transitioning Veteran population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samuel Bacharach, Ph.D.
- Phone Number: 212-340-2850
- Email: sb22@cornell.edu
Study Contact Backup
- Name: Paul D Bliese, Ph.D.
- Email: Paul.Bliese@moore.sc.edu
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98433
- Recruiting
- Joint Base Lewis-McChord
-
Contact:
- Sherry Matheney
- Phone Number: 253-477-4744
- Email: sherry.k.matheney.civ@army.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Is US solider intending to separate from active duty during the study enrollment period
- Intends to seek civilian employment
- Plans to live in US
Exclusion Criteria:
- Plans to retire and not seek civilian employment
- Plans to live outside of the US
- Is separating or retiring from the National Guard or Reserves
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention condition
Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study.
|
The internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices..
The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior.
|
No Intervention: Control
The control group will not be offered the internet-based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Heavy Episodic Drinking
Time Frame: Through study completion, an average of monthly over 15 months
|
Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
|
Through study completion, an average of monthly over 15 months
|
Change in Modal alcohol consumption
Time Frame: Through study completion, an average of monthly over 15 months
|
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
|
Through study completion, an average of monthly over 15 months
|
Change in Negative Emotional State -- Depression
Time Frame: Through study completion, an average of monthly over 15 months
|
The Patient Health Questionnaire (PHQ)-9
|
Through study completion, an average of monthly over 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Alcohol-related problems
Time Frame: Through study completion, an average of monthly over 15 months
|
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)
|
Through study completion, an average of monthly over 15 months
|
Change in Suicidal ideation
Time Frame: Through study completion, an average of monthly over 15 months
|
Measure developed by Nock et al., 2007
|
Through study completion, an average of monthly over 15 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Employment
Time Frame: Through study completion, an average of monthly over 15 months
|
Current job situation/Change employment
|
Through study completion, an average of monthly over 15 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Bacharach, Ph.D., Cornell University
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0009650
- W81XWH1920001;CDMRP-BA160401 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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