Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

Not Applicable

Completed

• Conditions: Written Exposure Therapy; Imaginal Exposure Therapy
• Interventions: Behavioral: Written Exposure Therapy; Behavioral: Imaginal Exposure Therapy

• Registration Number: NCT04000217
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Study Start: 2020-01-20
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written Exposure Therapy	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.
Imaginal Exposure Therapy	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.

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).	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.

Secondary Outcome Measures

Name	Time	Method
Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).	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.
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).	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.
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)	Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).	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.

Trial Locations

Locations (1)

Prevail Health Inc.; 🇺🇸 Chicago, Illinois, United States