跳至主要内容
临床试验/NCT00739765
NCT00739765已完成不适用

Psychotherapies for Chronic Post-Traumatic Stress Disorder

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Clinician-Administered PTSD Scale (CAPS)

研究概览

简要总结

This study will examine whether interpersonal psychotherapy is as effective in treating post-traumatic stress disorder as the established therapies of prolonged exposure and relaxation.

详细描述

Post-traumatic stress disorder (PTSD) is caused by a traumatic experience often involving physical harm or the threat of harm or death. The emotional numbness and traumatic flashbacks symptomatic of PTSD interfere with everyday life for approximately 7.7 million adults. Besides prescription drug treatment, only exposure-based therapies, like prolonged exposure (PE) therapy, have been proved effective in treating PTSD. Interpersonal psychotherapy (IPT), which is not based on exposure, is effective in treating mood disorders, and pilot studies indicate it may also be effective in treating PTSD. IPT treats patients by helping them to improve their interpersonal functioning, as opposed to PE, which helps patients by guiding them to recreate traumatic memories in safe circumstances. This study will determine whether IPT is as effective as PE, the gold standard, in treating PTSD. Relaxation therapy, a commonly used control therapy for studies of PTSD, will be used for that purpose here.

All participants will be screened for PTSD, with those meeting the criteria being randomly assigned to one of the following three treatment groups:

  • Group 1 participants will receive IPT. They will meet weekly for fourteen 50-minute sessions focusing on interpersonal consequences of the trauma affecting them and their relationships with others.
  • Group 2 participants will receive PE. They will meet for 10, unevenly spaced 90-minute sessions during which they will face the trauma responsible for their symptoms.
  • Group 3 participants will receive relaxation therapy. They will meet for nine 90-minute sessions and one 30-minute session during which they will learn relaxation methods.

All treatments will last 14 weeks, with assessments made by mental health professionals at screening, the midpoint of the study, the end of the study, and a 3-month follow-up. PTSD symptoms will be assessed through clinical interviews and self-report measures. In addition, participants will complete other interviews and tests that will examine a variety of factors relating to mental health, including comorbidity of other conditions, affect, social functioning, and quality of life.

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

  • Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for primary, chronic PTSD
  • At least moderately severe symptoms, defined by a minimum total (frequency plus severity) Clinician-Administered PTSD Scale score greater than 50
  • Willing to undergo an independent clinical assessment and other ratings

排除标准

  • Diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders
  • Psychiatric disorder due to a general medical condition
  • Current substance abuse or dependence
  • Acute suicide or homicide risk
  • Unstable or life-threatening medical condition
  • Primary diagnosis of borderline personality disorder, major depressive disorder, or major depression, melancholic subtype
  • Diagnosis of antisocial personality disorder
  • At least partial benefit from current treatment regimen
  • Unwillingness to discontinue current ineffective psycho- or pharmacotherapy
  • Inability to speak or read English

研究组 & 干预措施

3 Relaxation therapy

Active Comparator

Participants will receive relaxation therapy.

干预措施: Relaxation Therapy (Behavioral)

1 Interpersonal Psychotherapy (IPT)

Experimental

Participants will receive interpersonal psychotherapy.

干预措施: Interpersonal Psychotherapy (Behavioral)

2 Prolonged Exposure (PE)

Active Comparator

Participants will receive prolonged exposure therapy.

干预措施: Prolonged Exposure Therapy (Behavioral)

结局指标

主要结局

Clinician-Administered PTSD Scale (CAPS)

时间窗: After 14 weeks of treatment

Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores \>50 indicate at least moderately severe PTSD; scores \<20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156

次要结局

  • Hamilton Depression Rating Scale(After 14 weeks of treatment)

研究者

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

John Markowitz

Clinical Psychiatrist

New York State Psychiatric Institute

研究点 (1)

Loading locations...

相似试验

Effectiveness of Three Different Psychotherapies for... | 临床试验