Clinical trial NCT05390775: Written Exposure Therapy to Improve Lives After Stress Exposure
Official title: Written Exposure Therapy to Improve Lives After Stress Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Florida Health
name: Indiana University
name: University of Massachusetts, Worcester
name: Washington University School of Medicine
name: Henry Ford Health System
name: US Department of Veterans Affairs
First posted: 2022-05-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged to home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) are common in this population, and that individuals with a past history of traumatic stress exposure and/or posttraumatic stress symptoms, such as military veterans, are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot Written Exposure Therapy to Improve Lives after Stress Exposure (WISE) trial will assess the ability of written exposure therapy to reduce the incidence and severity of PTSD after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). Written exposure therapy is an evidence-based, low-cost intervention that has been demonstrated to be efficacious in treating chronic PTSD symptoms after a variety of traumatic stress exposures, including MVC. However, WISE has never been tested as a secondary preventive intervention. In addition, the efficacy of written exposure therapy when administered as a telehealth intervention has never been assessed, despite the fact that almost a quarter of US veterans live in rural communities that have greater barriers to obtaining in-person care. This WISE pilot trial will randomize 40 individuals who present to a study ED for care after MVC to five sessions of written exposure therapy vs. unemotional writing control. Both exposure and control interventions will be administered via telehealth (n=40), with 20 individuals receiving written exposure therapy and 20 receiving unemotional writing intervention. The same therapists will administer both interventions. Participants will be assessed via traditional self-report surveys. Results of this trial will demonstrate the feasibility and potential efficacy of WISE to reduce the development of PTSD after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial.

Eligibility criteria: Inclusion Criteria:

* Alert and oriented at time of screening
* Written and spoken English
* 18+ years of age
* Presenting to the Emergency Department (ED) within 72 hours of motor vehicle collision
* Discharged home after ED evaluation
* Have an email and mailing address
* iOS or android-compatible smart-phone with photo capability, without loss of cellular connection due to inability to pay bill for \>1 year, not shared with anyone else
* Meets Posttraumatic Stress Disorder (PTSD) risk score criteria
* Willing to participate in remote therapy sessions

Exclusion Criteria:

* Age \<18
* Pregnant
* Prisoner or in police custody
* Present to ED \>72 hours after trauma
* Have had a change in psychiatric medication regimen 1 month prior to presentation to ED
* Currently receiving cognitive behavioral therapy (CBT) or exposure-based psychological treatment
* Self-inflicted or occupational injury
* Ongoing reported domestic violence
* History or condition that in investigator's judgement would likely make a participant non-compliant/unsuitable for participation, including deafness or blindness

Primary outcomes:
measure: Change in PTSD Symptom Scores from Baseline to Month 3
timeFrame: Baseline, 3-months
measure: Change in PTSD Symptom Scores from Baseline to Month 2
timeFrame: Baseline, 2-months
measure: Change in PTSD Symptom Scores from Baseline to Month 1
timeFrame: Baseline, 1-month
Secondary outcomes:
measure: Change in Pain Symptom Score
timeFrame: Baseline, 3-months
measure: Change in Somatic Symptom Score
timeFrame: Baseline, 3-months
measure: Change in Depressive Symptoms Score
timeFrame: Baseline, 3-months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School (Umass Memorial Medical Center)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samuel McLean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: