NCT04000217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

June 24, 2019

Last Update Submit

February 28, 2023

Conditions

Written Exposure TherapyImaginal Exposure Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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).

  • 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).

  • 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).

Study Arms (2)

Written Exposure Therapy

ACTIVE COMPARATOR

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

Imaginal Exposure Therapy

ACTIVE COMPARATOR

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

Interventions

Written Exposure TherapyBEHAVIORAL

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).

Written Exposure Therapy
Imaginal Exposure TherapyBEHAVIORAL

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).

Imaginal Exposure Therapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevail Health Inc.

Chicago, Illinois, 60642, United States

Location

Related Publications (1)

  • McLean CP, Malek N, Straud CL. A pilot randomized controlled trial of online written exposure therapy delivered by peer coaches to veterans with posttraumatic stress disorder. J Trauma Stress. 2024 Jun;37(3):471-482. doi: 10.1002/jts.23020. Epub 2024 Feb 13.

    PMID: 38348490DERIVED

MeSH Terms

Interventions

Implosive Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 27, 2019

Study Start

January 20, 2020

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)