Written Exposure Therapy to Improve Lives After Stress Exposure

NCT05390775 | Completed

• 1 other identifier: 21-3008
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Change in Pain Symptom Score

  Baseline, 3-months

• Change in Somatic Symptom Score

  Baseline, 3-months

• Change in Depressive Symptoms Score

  Baseline, 3-months

Study Arms (2)

Written Exposure Therapy

EXPERIMENTAL

Behavioral: Written Exposure Therapy (WISE)

Non-emotional Writing

PLACEBO COMPARATOR

Behavioral: Non-emotional Writing

Interventions

Written Exposure Therapy (WISE) BEHAVIORAL

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.

Written Exposure Therapy

Non-emotional Writing BEHAVIORAL

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.

Non-emotional Writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alert and oriented at time of screening
• Written and spoken English
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Florida Health: collaborator
• Indiana University: collaborator
• University of Massachusetts, Worcester: collaborator
• Washington University School of Medicine: collaborator
• Henry Ford Health System: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (6)

University of Florida

Gainesville, Florida, 32608, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Massachusetts Chan Medical School (Umass Memorial Medical Center)

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Samuel McLean, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: August 17, 2022
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 12 months following publication and continuing for 36 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (6)