Stress Inoculation Training (SIT): An Evidence-Based, Military Aligned Psychological Performance and Health Sustainment Prototype
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility of augmenting existing/traditional Navy military training with the manualized SIT Core Protocol (CP) utilizing the established augmentation procedure set as measured by feasibility, utility, and satisfaction metrics (CSQ-8) and to examine the relative effectiveness of the SIT-CP by comparison to standard military training in a controlled trial examining outcomes of stress tolerance, psychological health, resilience and occupational performance in Sailors undergoing DCA Firefighting Training (pre- to post-training), while collecting implementation data.
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
- 是
入选标准
- •US Navy service members on Active Duty or Reserve status
- •be fluent in English.
- •be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- •have access to a SmartPhone, computer, or tablet to utilize and access the virtual classroom.
- •agree to undergo psychometric and operational performance testing and participate in ongoing assessments throughout the study duration.
- •be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study (with reasonable accommodations for military operational demands as they arise).
排除标准
- •Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
- •Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
- •Active severe substance abuse as assessed by the investigator in accordance with The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) Substance Abuse Disorder criteria, or presence of illicit substance abuse.
- •They are currently undergoing another form of treatment other than supportive therapy (>2 times per month).
- •Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.
结局指标
主要结局
Changes in perceived management of stress as assessed by the Perceived Stress Scale (PSS)
时间窗: Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)
This is a 10 item questionnaire and each is scored a 5 -point likert scale from 0(never) to 4(very often) for a score range of 0 to 40, higher total scores indicate higher perceived stress.
Change in resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)
时间窗: Baseline, about 3 weeks from baseline, about 6 weeks form baseline, about 11 weeks form baseline, end of study (an average of 19 weeks form baseline)
This is a 25 item questionnaire and each is scored on a 5-point Likert scale ranging from 0 (Not true at all) to 4 (True nearly all the time) for a maximum score of 100 higher score indicating more resilience
次要结局
- Successful presentation of the element in the training module as assessed by the SIT Feasibility Rubric(week 4)
- level of confidence with delivering the training elements within the Module and the full Module as assessed by the SIT Feasibility Rubric(week 4)
- Satisfaction as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)(week 11(end of study))
- Change in mental skills as assessed by the Test of Performance Strategies (TOPS)(Baseline, about 6 weeks form baseline, about week 11, end of study (19 weeks form baseline))
- Utility as assessed by the standardized self-assessment tool(week 4)
- Firefighting Observational Rubrics(week 6)
- Change in adaptation to stress as assessed by the Situational Adaptation to Stress Scale for Human Performance (SASS-HP)(about 11 weeks form baseline, end of study (about 19 weeks form baseline))
- Change in achievement score as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment(Baseline, week 11)
- Change in average coherence as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment Assessment(Baseline, week 11)
- Change in average heart beats per minute as assessed by the 10-Minute Heart Rate Variability Biofeedback assessment(Baseline, week 11)
研究者
Sarah Jackson
Associate Professor
The University of Texas Health Science Center, Houston