Written Exposure Therapy for Posttraumatic Stress Disorder

NCT ID: NCT01800773

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-09
• Study Completion Date: 2018-04-30

Brief Summary

Although evidence-based treatments for PTSD exist, a significant minority of individuals do not benefit from these treatments and many individuals to not seek treatment, citing barriers such as time commitment and expense of treatment. The goal of the proposed study is to establish an alternative PTSD treatment that is efficacious and efficient.

Detailed Description

Prior research has demonstrated that written exposure therapy (WET), is an efficient, well-tolerated, and efficacious treatment for PTSD. The proposed project takes the next step in establishing WET as an intervention for PTSD by examining whether WET is equally efficacious to an evidence-based treatment for PTSD. Using a randomized noninferiority controlled trial, 126 adults diagnosed with PTSD will be assigned to either WET or Cognitive Processing Therapy (CPT). Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD participants assigned to WET demonstrate PTSD symptom severity outcome that is noninferior to PTSD participants assigned to CPT. Secondary aims include examining whether expected treatment gains are sustained for both treatments and whether WET has a lower treatment dropout rate relative to CPT. Exploratory aims include examining moderators and mediators of WET and CPT. If the hypothesis that WET is noninferior to CPT is confirmed then a brief treatment option for PTSD will be established.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Written Exposure Therapy

Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner.

Group Type: EXPERIMENTAL

Written Exposure Therapy

Intervention Type: BEHAVIORAL

Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.

Cognitive Processing Therapy

cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study.

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.

Interventions

Written Exposure Therapy

Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• PTSD diagnosis
• if taking psychotropic medication, on stable dose for 2 months
• Ability to read and write in English

Exclusion Criteria

• not currently engaged in active PTSD treatment
• no current diagnosis of substance dependence
• no current diagnosis of psychosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise M. Sloan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

National Center for PTSD at VA Boston Healthcare System

Boston, Massachusetts, United States

Countries

United States

References

Sloan DM, Marx BP, Lee DJ, Resick PA. A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2018 Mar 1;75(3):233-239. doi: 10.1001/jamapsychiatry.2017.4249.

Reference Type: RESULT

PMID: 29344631 (View on PubMed)

Other Identifiers

1R01MH095737-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-31806

Identifier Type: -

Identifier Source: org_study_id