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Completed

NCT Number: NCT01600456

Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Psychological Sciences Department Case Western Reserve University, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged exposure (PE)

Behavioral

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

PE plus Sertraline

Other

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

Primary outcomes

  1. Posttraumatic stress disorder (PTSD) Symptoms

    Time frame: Measured up to 9 months.

    Interview measure to assess PTSD symptoms.

Secondary outcomes

  1. Depression symptoms

    Time frame: Measured up to 9 months.

    Clinical assessment of depression symptoms.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Washington

Registry information

Official study title

Optimizing PTSD Treatment: PE Versus PE Plus Sertraline

Acronym: OPT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 17, 2012
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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