Comparison of Two Treatments for Post-Traumatic Stress Disorder

April 28, 2022 updated by: Norah Feeny, Case Western Reserve University

Effectiveness of PTSD Treatment: CBT Versus Sertraline

This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exposure to traumatic events, such as automobile accidents and 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 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 CBT and the antidepressant sertraline.

Participants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT 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 antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly 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 antidepressant 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 24 months. Participants who do not respond to their assigned or chosen treatment will be offered 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, 12, and 24 months after the study treatment period.

Study Type

Interventional

Enrollment (Actual)

200

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
    • Washington
      • Seattle, Washington, United States, 98195
        • Department of Psychology, 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 diagnosis of PTSD
  • Experienced traumatic event at least 12 weeks prior to study entry
  • Willingness to discontinue current CBT or antidepressant treatment

Exclusion Criteria:

  • Current diagnosis of schizophrenia or delusional disorder
  • Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment
  • 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 either CBT or sertraline
  • Medical contraindication for sertraline

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT no choice
Participants will receive no choice cognitive behavioral therapy (CBT no choice)
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Names:
  • Prolonged exposure (PE)
Active Comparator: CBT choice
Participants will receive choice cognitive behavioral therapy (CBT choice)
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Names:
  • Prolonged exposure (PE)
Active Comparator: sertraline no choice
Participants will receive no choice sertraline (sertraline no choice)
Drug: Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
Other Names:
  • Zoloft
Active Comparator: sertraline choice
Participants will receive choice sertraline (sertraline choice)
Drug: Sertraline
The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptoms
Time Frame: Post-treatment, ten weeks
total score, range from 0-80, higher scores are more severe
Post-treatment, ten weeks
Depression Symptoms
Time Frame: Measured at Post-Treatment, at 10 weeks
Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression
Measured at Post-Treatment, at 10 weeks
State Anxiety
Time Frame: Measured at Post-Treatment, at 10 weeks
State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
Measured at Post-Treatment, at 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Functioning
Time Frame: Measured at Post-Treatment, at 10 weeks
Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment
Measured at Post-Treatment, at 10 weeks

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)

Investigators

  • Principal Investigator: Norah C. Feeny, PhD, Department of Psychology, Case Western Reserve University
  • Principal Investigator: Lori A. Zoellner, PhD, Department of Psychology, 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

September 1, 2004

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 8, 2005

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH066347 (U.S. NIH Grant/Contract)
  • R01MH066348 (U.S. NIH Grant/Contract)

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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