Written Exposure Therapy to Improve Lives After Stress Exposure
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: Written Exposure Therapy (WISE)Behavioral: Non-emotional Writing
- Registration Number
- NCT05390775
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Written Exposure Therapy Written Exposure Therapy (WISE) - Non-emotional Writing Non-emotional Writing -
- Primary Outcome Measures
Name Time Method Change in PTSD Symptom Scores from Baseline to Month 2 Baseline, 2-months The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Change in PTSD Symptom Scores from Baseline to Month 1 Baseline, 1-month The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Change in PTSD Symptom Scores from Baseline to Month 3 Baseline, 3-months The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80). Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
- Secondary Outcome Measures
Name Time Method Change in Pain Symptom Score Baseline, 3-months The Regional Pain Scale (RPS) is a 19 item scale developed to assess the extent of body pain. Each item is scored on a 0-10 pain scale where 0 is no pain and 10 is severe pain.
Change in Somatic Symptom Score Baseline, 3-months The Pennebaker Inventory of Limbic Languidness (PILL) is a 54-item scale that assesses the frequency of common physical symptoms and sensations. Data presented utilize items from the PILL with response options adapted for greater consistency across measures, greater precision in response levels, and to allow administration via self-report. Each item is scored on a 0-10 scale where 0 is "no problem" and 10 means "a severe problem" with the given symptom.
Change in Depressive Symptoms Score Baseline, 3-months The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b is an 8 item scale developed to assess depression in individuals 18 and older. Each item on the measures is rated on a five-point scale (1=never and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Questionnaires utilize the 8 items and the same response coding (1-5) with slightly altered response options (i.e. "never" is changed to "none of the time" and "always" is changed to "all or almost all of the time") adapted for greater consistency across measures, greater precision in response levels, and to allow administration via self-report.
Trial Locations
- Locations (6)
University of Florida
🇺🇸Gainesville, Florida, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Massachusetts Chan Medical School (Umass Memorial Medical Center)
🇺🇸Worcester, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States