Written Exposure Therapy to Improve Lives After Stress Exposure

Post Traumatic Stress Disorder Clinical Trial

— WISE  

Official title:

Written Exposure Therapy to Improve Lives After Stress Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390775
• Other study ID #: 21-3008
• Status: Completed
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: October 19, 2023

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Written Exposure Therapy (WISE)
WISE consists of five weekly sessions. At session one, the therapist will provide psychoeducation about PTSD, rationale for the proposed intervention, and then instructions for writing about their traumatic experience during each session. Psychoeducation and treatment rationale are scripted to ensure consistency. The participant will be instructed to write about the same trauma memory (their recent MVC) during each session. They will be asked to look back at the event and write for 30 minutes about the details of the event including what they saw, heard, felt, smelled, etc. without regard for spelling or grammar. The participant will self-report SUDs levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above.
• Non-emotional Writing
Following randomization, the first session for the control writing condition will be conducted as follows, which is detailed in a structured manual for therapists. The therapist will read instructions for writing about non-emotional topics. The participant will be instructed to describe what they did yesterday from the time they woke up until the time they went to bed, as objectively as possible, without regard for spelling or grammar. The therapist will then leave the participant with a written version of the instructions for 30 minutes while the participant writes. As discussed, the participant will self-report Subjective Unites of Distress Scale (SUDS) levels to the therapist at the beginning and end of each session. After 30 minutes, the therapist will ask the participant to stop writing, review the experience of writing and discuss as needed, and conclude the session. Therapists will collect the written narrative described above.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Massachusetts Chan Medical School (Umass Memorial Medical Center)	Worcester	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Henry Ford Health System, Indiana University, University of Florida Health, University of Massachusetts, Worcester, US Department of Veterans Affairs, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptom Scores from Baseline to Month 3	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.	Baseline, 3-months
Primary	Change in PTSD Symptom Scores from Baseline to Month 2	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.	Baseline, 2-months
Primary	Change in PTSD Symptom Scores from Baseline to Month 1	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.	Baseline, 1-month
Secondary	Change in Pain Symptom Score	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.	Baseline, 3-months
Secondary	Change in Somatic Symptom Score	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.	Baseline, 3-months
Secondary	Change in Depressive Symptoms Score	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.	Baseline, 3-months