Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

NCT ID: NCT04000217

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2022-09-09

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.

Detailed Description

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Conditions

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Written Exposure Therapy Imaginal Exposure Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Written Exposure Therapy

Intervention Type 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

Imaginal exposure therapy will involve verbal recounting of trauma memories for 30 minutes with therapist instruction and feedback before and after each recounting exercise.

Group Type ACTIVE_COMPARATOR

Imaginal Exposure Therapy

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Carmen McLean

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prevail Health Inc.

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38348490 (View on PubMed)

Other Identifiers

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640C89370

Identifier Type: -

Identifier Source: org_study_id

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