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Completed

NCT Number: NCT04000217

Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

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.

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Key information

Conditions

Written Exposure Therapy Imaginal Exposure Therapy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prevail Health Inc.

Chicago, Illinois, 60642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Written Exposure Therapy

Behavioral

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).

imaginal exposure therapy

Behavioral

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).

Primary outcomes

  1. Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)

    Time frame: 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 outcomes

  1. Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).

    Time frame: 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.

  2. Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)

    Time frame: 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.

  3. Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2019
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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