Comparison of Two Treatments for Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Effectiveness of PTSD Treatment: CBT Versus Sertraline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127673
• Other study ID #: R01MH066347
• Secondary ID: R01MH066348
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: August 2011

Study information

• Verified date: April 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Behavioral:
• Cognitive behavioral therapy (CBT)
CBT will include 10 weekly sessions of individual cognitive behavioral therapy.

Locations

Country	Name	City	State
United States	Department of Psychology, University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptoms	total score, range from 0-80, higher scores are more severe	Post-treatment, ten weeks
Primary	Depression Symptoms	Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression	Measured at Post-Treatment, at 10 weeks
Primary	State Anxiety	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	Quality of Life Functioning	Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment	Measured at Post-Treatment, at 10 weeks

External Links

•   Click here for more information about the effectiveness of CBT and sertraline for PTSD