Written Exposure Therapy (WISE) for Moral Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida, Gainesville, FL
Moral Injury+2 More
Written Exposure Therapy (WISE) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.

Eligible Conditions

  • Moral Injury
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Baseline, 3-months

Baseline, 1-month
Change in PTSD Symptom Scores from Baseline to Month 1
Baseline, 2-months
Change in PTSD Symptom Scores from Baseline to Month 2
Baseline, 3-months
Change in Depressive Symptoms Score
Change in PTSD Symptom Scores from Baseline to Month 3
Change in Pain Symptom Score
Change in Somatic Symptom Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Written Exposure Therapy
1 of 2
Non-emotional Writing
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Written Exposure Therapy (WISE) · Has Placebo Group · N/A

Written Exposure Therapy
Behavioral
Experimental Group · 1 Intervention: Written Exposure Therapy (WISE) · Intervention Types: Behavioral
Non-emotional Writing
Behavioral
PlaceboComparator Group · 1 Intervention: Non-emotional Writing · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3-months
Closest Location: University of Florida · Gainesville, FL
Photo of University of Florida 1Photo of University of Florida 2Photo of University of Florida 3
2007First Recorded Clinical Trial
0 TrialsResearching Moral Injury
783 CompletedClinical Trials

Who is running the clinical trial?

University of Florida HealthOTHER
6 Previous Clinical Trials
4,844 Total Patients Enrolled
Indiana UniversityOTHER
858 Previous Clinical Trials
543,542 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
306 Previous Clinical Trials
741,089 Total Patients Enrolled
Washington University School of MedicineOTHER
1,772 Previous Clinical Trials
2,270,641 Total Patients Enrolled
US Department of Veterans AffairsFED
853 Previous Clinical Trials
470,770 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,348 Previous Clinical Trials
3,908,566 Total Patients Enrolled
Henry Ford Health SystemOTHER
257 Previous Clinical Trials
2,011,135 Total Patients Enrolled
Samuel McLean, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a score of 3 or more on the Posttraumatic Stress Disorder (PTSD) risk score.
You are 18 years of age or older.
You have been discharged home from the emergency department after evaluation for a suspected acute illness.
You are willing to participate in remote therapy sessions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.