The Network Study: Soldiers Connecting for Work and Health

Depression Clinical Trial

Official title:

Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463225
• Other study ID #: IRB0009650
• Secondary ID: W81XWH1920001;CD
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: Cornell University
• Contact: Samuel Bacharach, Ph.D.
• Phone: 212-340-2850
• Email: sb22[@]cornell.edu
• 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 in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be recruited, with the intention of drawing a final sample of 450 participants. 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Depression

Intervention

Other:
• Internet-Delivered Brief Intervention
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.

Locations

Country	Name	City	State
United States	Joint Base Lewis-McChord	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Cornell University	University of South Carolina, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (73)

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* Note: There are 73 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, an average of monthly over 15 months
Primary	Change in Heavy Episodic Drinking	Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)	Through study completion, an average of monthly over 15 months
Primary	Change in Modal alcohol consumption	Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)	Through study completion, an average of monthly over 15 months
Primary	Change in Negative Emotional State -- Depression	The Patient Health Questionnaire (PHQ)-9	Through study completion, an average of monthly over 15 months
Secondary	Change in Alcohol-related problems	Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie & Pedersen)	Through study completion, an average of monthly over 15 months
Secondary	Change in Suicidal ideation	Measure developed by Nock et al., 2007	Through study completion, an average of monthly over 15 months