Comparison of Two Treatments for Post-Traumatic Stress Disorder

Phase 3

Completed

Conditions: Post-Traumatic Stress Disorder

Interventions: Behavioral: Cognitive behavioral therapy (CBT)
Drug: Sertraline

Registration Number: NCT00127673

Lead Sponsor: Case Western Reserve University

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT choice	Cognitive behavioral therapy (CBT)	Participants will receive choice cognitive behavioral therapy (CBT choice)
sertraline choice	Sertraline	Participants will receive choice sertraline (sertraline choice)
CBT no choice	Cognitive behavioral therapy (CBT)	Participants will receive no choice cognitive behavioral therapy (CBT no choice)
sertraline no choice	Sertraline	Participants will receive no choice sertraline (sertraline no choice)

Primary Outcome Measures

Name	Time	Method
State Anxiety	Measured at Post-Treatment, at 10 weeks	State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe
PTSD Symptoms	Post-treatment, ten weeks	total score, range from 0-80, higher scores are more severe
Depression Symptoms	Measured at Post-Treatment, at 10 weeks	Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression

Secondary Outcome Measures

Name	Time	Method
Quality of Life Functioning	Measured at Post-Treatment, at 10 weeks	Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment