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临床试验/NCT01674244
NCT01674244已完成不适用

Integrative Exercise for Post-Deployment Stress

Northern California Institute of Research and Education1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年3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
发起方
入组人数
40
试验地点
1
主要终点
Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only

研究概览

简要总结

Despite the considerable efforts of the DoD and VA to improve awareness of mental health problems and access to care, many returning veterans still report substantial barriers to seeking traditional mental health care. Research suggests that a significant barrier to pursuing treatment is the perception of stigma (Hoge at al., 2004). The primary objective of this 12-week pilot, randomized controlled trial (RCT) is to obtain pilot data on the utilization and efficacy of a standardized, integrative exercise protocol (aerobic exercise and mindful breath training) in addressing global post-traumatic stress disorder (PTSD) symptoms, sleep disturbances, and non-sleep PTSD symptoms in veterans with PTSD. Specifically, this study will examine whether a 12-week course of Integrative Exercise therapy, a treatment lacking stigma, 1) produces significant pre-post improvements in PTSD symptoms and sleep disturbances (compared to a Monitor Only Waitlist condition) 2) improves other clinical outcomes including mood, alcohol and non-alcohol substance use, psychological distress, mindfulness, and overall quality of life (compared to a Monitor Only Waitlist condition) and 3) whether such treatment is feasible and acceptable.

A secondary aim of this study is to evaluate possible mechanisms underlying these effects such as chemicals in the blood related to stress, changes in brain imaging markers, aerobic capacity, and improved sleep.

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
None

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
否

入选标准

  • •Between the ages of 18-65 and must be physically able to participate in an exercise program
  • •Participants will meet criteria for either current, full syndromal PTSD of at least 3 months duration, as indexed by the Clinician Administered PTSD Scale (CAPS) diagnostic criteria or partial PTSD defined by meeting the required number of symptoms in the B symptom cluster as well as the required number of symptoms in either the C or D symptom clusters.

排除标准

  • •Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, or mania or meet criteria for drug or alcohol dependence within the past year as assessed by the Structured Clinical Interview for DSM-IV-TR.
  • •Prominent suicidal or homicidal ideation
  • •Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months
  • •Pregnant, have a clinically significant neurologic disorder, systemic illness affecting CNS function, history of seizure disorder, asthma, and/or physical disabilities making it impossible to use exercise equipment will be excluded
  • •Myocardial infarction (MI) in the past 6 months
  • •Moderate to severe Traumatic Brain Injury (any history of head trauma associated with the onset of persistent cognitive complaints, neurological symptoms, or loss of consciousness > 5 minutes)

研究组 & 干预措施

Integrative Exercise

Experimental

Subjects will exercise for 12 weeks (3 times weekly, with each total workout being approximately 60 minutes in length). The exercise protocol will incorporate elements of mindfulness, cardiovascular strengthening, and controlled breathing.

干预措施: Integrative Exercise (Behavioral)

Monitor Only Waitlist

Active Comparator

Monitor Only Waitlist

干预措施: Monitor Only Waitlist (Behavioral)

结局指标

主要结局

Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only

时间窗: 12 weeks

Self-reported sleep quality comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only

时间窗: 12 weeks

Hippocampal subfield volume comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
Northern California Institute of Research and Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas C. Neylan, M.D.

Professor in Residence

Northern California Institute of Research and Education

研究点 (1)

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