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The Network Study: Soldiers Connecting for Work and Health

Primary Purpose

Alcohol Use Disorder, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Delivered Brief Intervention
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 Negative Emotional States, Anxiety, Alcohol norms, Trauma, PTSD, Stress, Self-medication

Eligibility Criteria

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

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

Sites / Locations

  • Joint Base Lewis-McChordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

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 three times during the course of the study.

The control group will not be offered the internet-based intervention.

Outcomes

Primary Outcome Measures

Change in Heavy Episodic Drinking
Description 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
Measure developed by Nock et al., 2007

Full Information

First Posted
June 24, 2020
Last Updated
May 24, 2023
Sponsor
Cornell University
Collaborators
University of Washington, University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04463225
Brief Title
The Network Study: Soldiers Connecting for Work and Health
Official Title
Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
University of Washington, University of South Carolina

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Depression
Keywords
Negative Emotional States, Anxiety, Alcohol norms, Trauma, PTSD, Stress, Self-medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive three opportunities to engage with a personalized internet-delivered brief intervention over the course of seven months and the second group will not be granted access.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention condition
Arm Type
Other
Arm Description
Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not be offered the internet-based intervention.
Intervention Type
Other
Intervention Name(s)
Internet-Delivered Brief Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heavy Episodic Drinking
Description
Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Time Frame
Through study completion, an average of monthly over 15 months
Title
Change in Modal alcohol consumption
Description
Daily Drinking Questionnaire (DDQ) (Collins, Parks, & Marlatt, 1985)
Time Frame
Through study completion, an average of monthly over 15 months
Title
Change in Negative Emotional State -- Depression
Description
The Patient Health Questionnaire (PHQ)-9
Time Frame
Through study completion, an average of monthly over 15 months
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, an average of monthly over 15 months
Title
Change in Suicidal ideation
Description
Measure developed by Nock et al., 2007
Time Frame
Through study completion, an average of monthly over 15 months
Other Pre-specified Outcome Measures:
Title
Change in Employment
Description
Current job situation/Change employment
Time Frame
Through study completion, an average of monthly over 15 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The study will recruit up to 700 soldiers intending to separate from the Army in the initial phase of the study with the intention of securing a final sample of 450. Of the 450, 400 will be selected regardless of gender, but an additional 50 female soldiers will be recruited intentionally.
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Bacharach, Ph.D.
Phone
212-340-2850
Email
sb22@cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paul D Bliese, Ph.D.
Email
Paul.Bliese@moore.sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Bacharach, Ph.D.
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Base Lewis-McChord
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Matheney
Phone
253-477-4744
Email
sherry.k.matheney.civ@army.mil

12. IPD Sharing Statement

Plan to Share IPD
No
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