Brief Treatment for Posttraumatic Stress Disorder

NCT ID: NCT03033602

Last Updated: 2023-05-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-20

Study Completion Date

2021-03-31

Brief Summary

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The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.

Detailed Description

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The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Written exposure therapy

5 sessions of imaginal exposure therapy.

Group Type EXPERIMENTAL

written exposure therapy

Intervention Type BEHAVIORAL

five sessions of writing about traumatic experience.

CPT, cognitive only

12 sessions of cognitive therapy.

Group Type ACTIVE_COMPARATOR

CPT, cognitive only

Intervention Type BEHAVIORAL

12 sessions of cognitive therapy related to traumatic experience.

Interventions

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written exposure therapy

five sessions of writing about traumatic experience.

Intervention Type BEHAVIORAL

CPT, cognitive only

12 sessions of cognitive therapy related to traumatic experience.

Intervention Type BEHAVIORAL

Other Intervention Names

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WET CPT-C

Eligibility Criteria

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Inclusion Criteria

* Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD
* Diagnosis of PTSD
* Ability to speak, read and write English
* Not currently engaged in psychosocial treatment for PTSD
* Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.

Exclusion Criteria

* Current suicide or homicide risk meriting crisis intervention
* Active psychosis
* Moderate to severe brain damage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas

OTHER

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Boston VA Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denise Sloan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston VA Research Institute, Inc.

Locations

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Ft. Hood

Killeen, Texas, United States

Site Status

University of Texas Health Science Center, San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.

Reference Type BACKGROUND
PMID: 35015065 (View on PubMed)

Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar.

Reference Type BACKGROUND
PMID: 31890987 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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W81WH-15-1-0391

Identifier Type: -

Identifier Source: org_study_id

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