Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

A Randomized Control Trial Comparing Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy Delivered Online

The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.

Study Overview

• Status: Completed
• Conditions: Written Exposure Therapy; Imaginal Exposure Therapy
• Intervention / Treatment: Behavioral: Written Exposure Therapy; Behavioral: Imaginal Exposure Therapy

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60642
      • Prevail Health Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to read/write English
• Internet connection allowing stable access to the Vets Prevail website
• A clinically significant PCL-5 score of 31 or above.

Exclusion Criteria:

• A score on the suicidality item of the PHQ-9 of 3 or higher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Written Exposure Therapy; Written exposure therapy (Sloan et al., 2012) is a brief evidence-based treatment for PTSD (US Dept. of VA & DoD, 2017), wherein patients are asked to write about their trauma memories for 30 minutes, with therapist instruction and feedback before and after each writing exercise.	Behavioral: Written Exposure Therapy; In this study, written exposure therapy is delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).
Active Comparator: Imaginal Exposure Therapy; Imaginal exposure therapy will involve verbal recounting of trauma memories for 30 minutes with therapist instruction and feedback before and after each recounting exercise.	Behavioral: Imaginal Exposure Therapy; Delivery of imaginal exposure in this study will mirror the procedures used in WET. It will be delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)	Self report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate greater PTSD severity.	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).	Self report measure of depression symptoms. It is the 9-item measure that yields a total score of 0-27, with higher scores indicating greater depressive symptom severity.	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)	A 16-item self report measure of difficulties in emotion regulation. Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)	A 5-item self-report measure of work and social functioning and impact of symptoms. Total scores range from 0-40 with higher scores indicating greater impairment.	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 640C89370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No