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临床试验/NCT00127673
NCT00127673已完成3 期

Effectiveness of PTSD Treatment: CBT Versus Sertraline

Case Western Reserve University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
200
试验地点
1
主要终点
State Anxiety

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of PTSD
  • Experienced traumatic event at least 12 weeks prior to study entry
  • Willingness to discontinue current CBT or antidepressant treatment

排除标准

  • 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

研究组 & 干预措施

CBT no choice

Active Comparator

Participants will receive no choice cognitive behavioral therapy (CBT no choice)

干预措施: Cognitive behavioral therapy (CBT) (Behavioral)

CBT choice

Active Comparator

Participants will receive choice cognitive behavioral therapy (CBT choice)

干预措施: Cognitive behavioral therapy (CBT) (Behavioral)

sertraline no choice

Active Comparator

Participants will receive no choice sertraline (sertraline no choice)

干预措施: Sertraline (Drug)

sertraline choice

Active Comparator

Participants will receive choice sertraline (sertraline choice)

干预措施: Sertraline (Drug)

结局指标

主要结局

State Anxiety

时间窗: 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

时间窗: Post-treatment, ten weeks

total score, range from 0-80, higher scores are more severe

Depression Symptoms

时间窗: Measured at Post-Treatment, at 10 weeks

Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression

次要结局

  • Quality of Life Functioning(Measured at Post-Treatment, at 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norah Feeny

Professor

Case Western Reserve University

研究点 (1)

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