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临床试验/NCT01998100
NCT01998100已完成3 期

Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)

University of Texas at Austin4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
28
试验地点
4
主要终点
PTSD Symptoms

研究概览

简要总结

The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition the two strategies (i.e., exercise + therapy and therapy alone condition) will be compared in terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth of new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptoms PTSD improvement.

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

  • You have PTSD.
  • You are between the ages of 18 and
  • You have written physician approval/medical clearance to participate in an exercise protocol.
  • You are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

排除标准

  • You are currently participating in a structured exercise program.
  • You have severe depression.
  • You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder.
  • You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months.
  • You have any history of a suicide attempt, or are at a significant risk or self-harm or harm to others.
  • You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction.

结局指标

主要结局

PTSD Symptoms

时间窗: 3 months

Self-report measure that assesses PTSD symptoms. Will be assessed at each visit throughout the three month protocol.

次要结局

  • General Mood and Anxiety Symptoms(3 months)
  • BDNF (by blood sample)(3 months)

研究者

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

Mark B. Powers

Research Associate Professor

University of Texas at Austin

研究点 (4)

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