The Network Study: Soldiers Connecting for Work and Health

NCT04463225 | Unknown

• 2 other identifiers: IRB0009650W81XWH1920001;CDMRP-BA160401
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Depression

Keywords

Negative Emotional States; Anxiety; Alcohol norms; Trauma; PTSD; Stress; Self-medication

Outcome Measures

Primary Outcomes (3)

• 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

• Change in Modal alcohol consumption

  Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)

  Through study completion, an average of monthly over 15 months

• Change in Negative Emotional State -- Depression

  The Patient Health Questionnaire (PHQ)-9

  Through study completion, an average of monthly over 15 months

Secondary Outcomes (2)

• Change in Alcohol-related problems

  Through study completion, an average of monthly over 15 months

• Change in Suicidal ideation

  Through study completion, an average of monthly over 15 months

Other Outcomes (1)

• Change in Employment

  Through study completion, an average of monthly over 15 months

Study Arms (2)

Intervention condition

OTHER

Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study.

Other: Internet-Delivered Brief Intervention

Control

NO INTERVENTION

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

Interventions

Internet-Delivered Brief Intervention OTHER

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.

Intervention condition

Eligibility Criteria

• Age: 18 Years - 62 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is US solider intending to separate from active duty during the study enrollment period
• Intends to seek civilian employment
• Plans to live in US

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• University of Washington: collaborator
• University of South Carolina: collaborator

Study Sites (1)

Joint Base Lewis-McChord

Tacoma, Washington, 98433, United States

RECRUITING

Related Publications (73)

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MeSH Terms

Conditions

Alcoholism; Depression; Anxiety Disorders; Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Samuel Bacharach, Ph.D.

  Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Bacharach, Ph.D.

CONTACT

212-340-2850; sb22@cornell.edu

Paul D Bliese, Ph.D.

CONTACT

Paul.Bliese@moore.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 9, 2020
• Study Start: March 30, 2021
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)