Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Written Exposure Therapy, Imaginal Exposure Therapy

Intervention / Treatment
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* Behavioral: Written Exposure Therapy
* Behavioral: Imaginal Exposure Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Written Exposure Therapy<br>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<br>* 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).<br>|
| Active Comparator: Imaginal Exposure Therapy<br>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<br>* 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).<br>|

What is the study measuring?
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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). |