NCT01800773

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 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

February 15, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

March 9, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

February 15, 2013

Last Update Submit

January 14, 2019

Conditions

Keywords

PTSDexposure treatmentclinical trialtrauma

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS)

    Total score on the CAPS will be used to assess change in PTSD symptom severity from baseline (pre-treatment) until 36- weeks post first treatment session.

    change from baseline PTSD symptom severity at 36 weeks post first treatment session

Secondary Outcomes (1)

  • treatment dropout

    course of treatment

Study Arms (2)

Written Exposure Therapy

EXPERIMENTAL

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

Behavioral: Written Exposure Therapy

Cognitive Processing Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Processing Therapy

Interventions

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

Written Exposure Therapy

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

Cognitive Processing Therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for PTSD at VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Denise M. Sloan, Ph.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 28, 2013

Study Start

March 9, 2013

Primary Completion

January 10, 2018

Study Completion

April 30, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations