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WEB-ED+ Treatment Arm for Post-Traumatic Stress Disorder (eSDM Trial)

N/A
Waitlist Available
Led By Anne G. Sadler, PhD RN
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year of treatment intervention
Awards & highlights

eSDM Trial Summary

This trial is studying an online mental health screening tool for veterans of the wars in Iraq and Afghanistan.

Eligible Conditions
  • Post Traumatic Stress Disorder
  • Substance Use Disorder
  • Depression
  • Traumatic Brain Injury

eSDM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year of treatment intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year of treatment intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VA mental health treatment engagement validated by VA electronic medical record review.
Secondary outcome measures
Shared Decision Making Interface between VA clinician and Veteran validated by VA electronic medical record review

eSDM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WEB-ED+ Treatment ArmExperimental Treatment1 Intervention
Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the WEB-ED+ Group. WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If successful, this enhancement could be integrated into the next iteration of WEB-ED. Enhancements include: An eHealth interface tailored to Veterans' VA and MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV premium status enrollment, and secure messaging guidance. Shared decision making (SDM) interface: Veteran SDM-related educational (e.g., existing YouTube videos) and structured questions about treatment concerns, preferences, and questions and can be accessed through postal and email distribution or Pharos portal. Access to a health coach (the research coordinators) will be available through a toll-free number to assist both Veterans and providers/Transition Patient Advocates.
Group II: WEB-ED Only Control ArmActive Control1 Intervention
Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the no intervention control group will receive no further intervention but asked to participate in a subsequent study phase that addresses VA and post-deployment care access
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WEB-ED+ Treatment Arm
2018
N/A
~1590

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,305,020 Total Patients Enrolled
Anne G. Sadler, PhD RNPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
1 Previous Clinical Trials
171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any recruitment opportunities for this research project?

"The information found on clinicaltrials.gov reveals that this trial has closed its recruitment process, having first been posted in June 2018 and last updated November 2022. Despite the closure of this study, there are currently 2,020 other medical trials actively seeking participants to join their studies."

Answered by AI
~232 spots leftby Apr 2025