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

August 2, 2021 updated by: Norah Feeny, Case Western Reserve University

Optimizing PTSD Treatment: PE Versus PE Plus Sertraline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exposure to traumatic events, such as automobile accidents and physical or sexual assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT (cognitive behavior therapy) and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of prolonged exposure and prolonged exposure plus the antidepressant sertraline.

Participants will either be randomly assigned to prolonged exposure (PE) or PE plus sertraline, or they will be able to choose one of the two treatments,which will be given for 10 weeks, followed by 9 months of follow-up assessments. Participants in the PE group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the PE plus sertraline group receive the same treatment as the PE group plus they will take sertraline daily for 10 weeks. These participants will be seen regularly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the PE plus sertraline group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 9 months. Participants who do not respond to their assigned or chosen treatment will be offered booster sessions or the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, and 9 months after the study treatment period.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Psychological Sciences Department Case Western Reserve University
    • Washington
      • Seattle, Washington, United States, 98195
        • Psychology Department of University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV (Diagnostic & Statistical Manual of Mental Disorders) diagnosis of PTSD (with severity threshold)
  • Experienced traumatic event at least 12 weeks prior to study entry
  • Willingness to discontinue current CBT or antidepressant treatment if needed

Exclusion Criteria:

  • Current diagnosis of schizophrenia or delusional disorder
  • Medically unstable bipolar disorder, depression with psychotic features, or depression requiring immediate psychiatric treatment
  • No clear trauma memory or trauma before age 3
  • Current diagnosis of alcohol or substance dependence within 3 months prior to study entry
  • Ongoing intimate relationship with the perpetrator of the traumatic event
  • History of nonresponse to adequate trial of either CBT or sertraline
  • Medical contraindication for sertraline
  • Current high dose use of benzodiazepines
  • Pregnant or sexually active female without adequate birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Choice: Prolonged exposure (PE)
Participants randomized to "choice" who choose prolonged exposure (PE).
Behavioral: Prolonged exposure (PE)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
ACTIVE_COMPARATOR: Choice: PE plus sertraline
Participants randomized to "choice" who choose PE plus sertraline.
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.
Other Names:
  • Zoloft
ACTIVE_COMPARATOR: No choice: Prolonged exposure (PE)
Participants randomized to "no choice" who are then randomized to PE.
Behavioral: Prolonged exposure (PE)
PE will include 10 weekly sessions of individual cognitive behavioral therapy.
ACTIVE_COMPARATOR: No Choice: PE plus sertraline
Participants randomized to "no choice" who are then randomized to PE plus sertraline.
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.
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic stress disorder (PTSD) Symptoms
Time Frame: Measured up to 9 months.
Interview measure to assess PTSD symptoms.
Measured up to 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression symptoms
Time Frame: Measured up to 9 months.
Clinical assessment of depression symptoms.
Measured up to 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

National Institute of Mental Health (NIMH)
University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

May 11, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Optimizing1
  • R01MH066348-07 (NIH)
  • R01MH066347-07 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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