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Comparison of Two Treatments for Post-Traumatic Stress Disorder

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), June 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00127673
  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 III

MedlinePlus related topics:   Anxiety    Post-Traumatic Stress Disorder    Stress   

ChemIDplus related topics:   Sertraline hydrochloride    Sertraline   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Effectiveness of PTSD Treatment: CBT Versus Sertraline

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:   360
Study Start Date:   September 2004
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Participants will receive no choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
2: Active Comparator
Participants will receive choice cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.
3: Active Comparator
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.
4: Active Comparator
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.

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 hypothesis: Both sertraline and cognitive behavior therapy (CBT), or prolonged exposure, will reduce symptoms of PTSD.

  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

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

Contacts
Contact: Christie Jackson, PhD     christie.jackson@nyumc.org    

Locations
United States, Ohio
Department of Psychology, Case Western Reserve University     Recruiting
      Cleveland, Ohio, United States, 44106
      Contact: Jennifer Fabritius, BA     216-368-0338     jennifer.fabritius@case.edu    
      Principal Investigator: Norah C. Feeny, PhD            
United States, Washington
Department of Psychology, University of Washington     Recruiting
      Seattle, Washington, United States, 98195
      Contact: Kelly Parker-Maloney, BS     206-685-3617     kelita@u.washington.edu    
      Principal Investigator: Lori A. Zoellner, PhD            

Sponsors and Collaborators

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

Click here for more information about the effectiveness of CBT and sertraline for PTSD  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Case Western Reserve University ( Norah Feeny, PhD )
Study ID Numbers:   R01 MH66347, R01 MH66348, DSIR 83-ATAS
First Received:   August 5, 2005
Last Updated:   June 6, 2008
ClinicalTrials.gov Identifier:   NCT00127673
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Antidepressants  
Cognitive behavior therapy  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Sertraline
Stress Disorders, Post-Traumatic
Stress
Serotonin
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008




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