Comparison of Two Treatments for Post-Traumatic Stress Disorder - Full Text View

Sponsor:	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

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:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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:	June 2011
Estimated Primary Completion Date:	June 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

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

Locations

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

Sponsors and 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

More Information

Additional Information:

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

No publications provided

Responsible Party:	Norah Feeny, PhD, Case Western Reserve University
ClinicalTrials.gov Identifier:	NCT00127673 History of Changes
Other Study ID Numbers:	R01 MH066347, R01 MH66348, DSIR 83-ATAS
Study First Received:	August 5, 2005
Last Updated:	May 26, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Antidepressants
Cognitive behavior therapy

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012