Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •US Military Veterans / Service Members
- •diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of >33
- •history of combat trauma and/or military service in an imminent danger pay area
- •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 or tablet to utilize the mobile health app and/OR access the virtual classroom.
- •agree to undergo psychometric 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.
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 DSM-5 Substance Abuse Disorder criteria, an AUDIT score > 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (< 3 times weekly).
- •They are currently undergoing another form of treatment other than supportive therapy (> 2 times per month).
- •Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
- •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
Change in average heart rate as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
时间窗: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Heart rate is measured in beats per minute
Change in achievement score as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
时间窗: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Achievement is measured via mathematical equation that includes coherence and heart rate variability and beats per minute over time. Higher achievement is associated with higher coherence sustained over time.
Patient satisfaction as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
时间窗: end of treatment (11-14 weeks)
The CSQ-8 is an 8-item measurement of global satisfaction. The range of possible scores is 8-32; higher scores indicate higher satisfaction with treatment. Items are measured on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied, poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent).
Increasing resilience as assessed by The Connor-Davidson Resilience Scale-10 (CD-RISC-10)4
时间窗: end of study (about 11-14 weeks after baseline)
This is a 10 item questionnaire , each is scored from 0(not true at all) to 4(true nearly all the time) for a maximum score of 40, higher score indicating better outcome
Satisfaction with care as assessed by the Client Satisfaction Questionnaire (8-item; CSQ-8)
时间窗: end of study (about 11-14 weeks after baseline)
This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome
Reduced symptoms of PTSD as assessed by the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
时间窗: end of study (about 11-14 weeks after baseline)
This is a 20 item questionnaire , each is scored from 0(not at all) -4( extremely)for a maximum score of 80, higher score indicating worse outcome
Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8-item (CSQ-8)
时间窗: 4 weeks after baseline
This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome
Satisfaction with care as assessed by the Client Satisfaction Questionnaire-8 item ( CSQ-8)
时间窗: 8 weeks after baseline
This is an 8 item questionnaire , each is scored on a 4-point Likert scale where 1 indicates low satisfaction with care (e.g., quite dissatisfied,poor) and 4 indicates high satisfaction with care (e.g., very satisfied, excellent). for a score range of 8-32, higher score indicating better outcome
Change in average coherence(heart rate variability) as assessed by the emWave Inner Balance personal biofeedback device by HeartMath
时间窗: Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks)
Heart rate variability is measured via a mathematical algorithm called coherence
次要结局
- Change in difficulty to fall sleep as assessed by the Insomnia Severity Index (ISI)(Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks))
- Change in severity of depression as assessed by the Patient Health Questionnaire (PHQ-9)(Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks))
- Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference scale(Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks))
- Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity scale(Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks))
- Change in adaptability to stress as assessed by the Situational Adaptation to Stress Scale (SASS-HSR)(Baseline , 4-6 weeks(mid treatment), end of treatment (11-14 weeks))
研究者
Sarah Jackson
Associate Professor
The University of Texas Health Science Center, Houston