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Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline

NCT01600456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-03

No results posted yet for this study

Summary

The specific aims of this study are:

1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline).
2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment.
3. To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment.
4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.

Conditions

Interventions

BEHAVIORAL

Prolonged exposure (PE)

PE will include 10 weekly sessions of individual cognitive behavioral therapy.

OTHER

PE plus Sertraline

PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Norah C Feeny, PhD · Case Western Reserve University

  • Lori A Zoellner, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600456 on ClinicalTrials.gov