Comparison of Two Treatments for Post-Traumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Norah Feeny, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00127673
First received: August 5, 2005
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Sertraline
Behavioral: Cognitive behavioral therapy (CBT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of PTSD Treatment: CBT Versus Sertraline

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • PTSD symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
  • Depression symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life functioning [ Time Frame: Measured at Months 3, 6, 12, and 24 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive no choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Name: Prolonged exposure (PE)
Active Comparator: 2
Participants will receive choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
Other Name: Prolonged exposure (PE)
Active Comparator: 3
Participants will receive no choice sertraline
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 Name: Zoloft
Active Comparator: 4
Participants will receive choice sertraline
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 Name: Zoloft

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127673

Locations
United States, Washington
Department of Psychology, University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Case Western Reserve University
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
  More Information

Additional Information:
No publications provided by Case Western Reserve University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norah Feeny, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00127673     History of Changes
Other Study ID Numbers: R01 MH066347, R01MH066347, R01 MH66348, DSIR 83-ATAS
Study First Received: August 5, 2005
Last Updated: January 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Case Western Reserve University:
Antidepressants
Cognitive behavior therapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014