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临床试验/NCT01599624
NCT01599624已完成不适用

Stress Resilience Training System

United States Naval Medical Center, San Diego0 个研究点目标入组 68 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
主要终点
Perceived Stress Scale-10

研究概览

简要总结

The Stress Resilience Training System (SRTS) program is a stress reduction and resilience building system that blends cognitive training to anticipate the effects of stress with advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning framework on an iPad platform.

The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and class/operational performance among United States Navy service members.

详细描述

Military operations and training situations present many physical and psychological challenges for service members to adapt to and overcome. The challenges of these changing conditions necessitate having to cope with stress, which is seen as the negative perceptions, feelings, and emotions that manifest from the subjective physical and/or mental strain on life processes. In addition, service members are returning from deployments having gone through traumatic experiences that can develop into posttraumatic stress disorder (PTSD), depression or other serious conditions.

In an increasing number of military personnel, the adverse effects of service and particularly of stressful combat exposure are significant, long lasting and possibly fatal. Most stress research is focused on treatment, but because stress effects are liable to appear years after exposure, it is imperative that methodologies be developed to mitigate the adverse effects of military-related stress and prevent its post-exposure effects.

It has long been accepted that warfighters adapt to combat stress after the first few experiences and that training can help duplicate this process, with recent studies showing that experienced military personnel are able to control and even utilize stress productively. A key part of what experienced personnel learn is self-awareness of their stress state and self-regulation of stress energy in order to maintain or even improve performance. These skills can be greatly enhanced by combining cognitive learning methodologies grounded in learning theory and biofeedback techniques based on Heart Rate Variability (HRV) with innovative simulation and game-based training tools.

The Stress Resilience Training System (SRTS) program is a stress reduction and resilience building system that blends cognitive training to anticipate the effects of stress with advanced biofeedback to mitigate stress effects and aftereffects, using a game-based learning framework on an iPad platform.

The proposed study will evaluate the effectiveness of the SRTS program at reducing perceived stress, PTSD symptoms, depression, anxiety, sleep quality, coping, attrition and class/operational performance among United States Navy service members.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Subjects must be Sailors attached to the Training Support Center San Diego (USN).
  • All genders and ethnic groups are to be included in the study.

排除标准

  • Subjects will be excluded from participation if they will not be at the command for a minimum of 4 months from the start date.

结局指标

主要结局

Perceived Stress Scale-10

时间窗: baseline, 2 months, 4 months

This is a 10-item scale designed to measure the degree to which a person perceives aspects of their life as uncontrollable, unpredictable and overwhelming. Participants are asked to indicate how often they have felt a certain way in the last month. The scale utilizes a 5-point likert format with responses ranging from never to very often.

Pittsburgh Sleep Quality Index (PSQI)

时间窗: baseline, 2 months, 4 months

The scale consists of seven different components of sleep quality that sum to an overall sleep quality score. A global score of 0-5 indicates good sleep quality while a global score greater than 5 indicates poor sleep quality. The global score as well as the sleep latency and habitual sleep efficiency scores will be used as continuous variables (Buysse, 1989).

Generalized Anxiety Disorder Measure (GAD-7)

时间窗: baseline, 2 months, 4 months

The scale was initially developed to screen for generalized anxiety disorder, but has sensitivity and specificity to panic, social anxiety, and PTSD. The instructions ask respondents to indicate how often they have been bothered by problems over the past two weeks. Scores are obtained from likert responses that range from 0 "Not at all" to 4 "Nearly every day". The total score can range from 0 to 21, with scores of 5, 10, and 15 being cutpoints for mild, moderate, and severe anxiety, respectively. The measure will be utilized to gain anxiety symptom severity scores (Spitzer et al., 2006).

次要结局

  • PTSD Checklist -Civilian Version (PCL-C)(baseline, 2 months, 4 months)
  • Patient Health Questionnaire (PHQ-9)(baseline, 2 months, 4 months)
  • Response to Stressful Experiences Scale (RSES)(baseline, 2 months, 4 months)
  • Brief COPE(baseline, 2 months, 4 months)
  • Unit Support(baseline, 2 months, 4 months)
  • Quality of Life Scale (QOLS)(baseline, 2 months, 4 months)
  • Performance Indicator(4 months)
  • Attrition Rate(4 months)

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Sponsor

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