A Randomized Waitlist-controlled Trial to Evaluate of the Effectiveness of Immediate Treatment Compared to Deferred Treatment With the Fisher Wallace Stimulator FW-200 Device in First Responders With Self-reported Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Beck Anxiety Inventory (BAI) scores
研究概览
简要总结
The goal of this clinical trial is to learn if the Fisher Wallace Stimulator FW-200 experimental device is effective at treating self-reported anxiety in first responders. The main question the trial aims to answer is does the FW-200 device improve anxiety as measured by a validated questionnaire.
详细描述
This is a randomized waitlist-controlled trial to evaluate the efficacy and safety of the Fisher Wallace Stimulator FW-200 device in the treatment of self-reported anxiety in police personnel and first responders. Participants will be randomly assigned to receive immediate treatment or deferred treatment with the FW-200 device.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Ability to read and write in English
- •First responder employee or employee of participating police department
- •Beck Anxiety Inventory total score above 7
- •Able to commit to two 20-minute device treatment session per day for up to 8 weeks
- •Willing to wear an actigraphy device
排除标准
- •Use of brain stimulation device in the last year
- •Have a pacemaker, electronic stent or electronic implants
- •Started or planning to start new medial treatment or health program over the next 8 weeks
- •Contemplated suicide in the past year
- •Institutionalized for mental health issues
- •Have a serious medical condition
- •Currently taking medications affecting the nervous system
- •Allergic to nickel
- •Currently taking or planning to take part in any other study on insomnia, anxiety or other mental health effort over the next 8 weeks
- •Currently pregnant or planning to become pregnant in the next 10 weeks
结局指标
主要结局
Beck Anxiety Inventory (BAI) scores
时间窗: From baseline to week 2
Change in Beck Anxiety Inventory (BAI) scores at Week 2 versus baseline in immediate treatment group compared to the deferred treatment group. Total score range is a minimum of 0 to a maximum of 63. Higher score means a worse severity of anxiety.
次要结局
- Consenting to Study Continuation(Week 4)
- Patient Health Questionnaire(From baseline to week 2 and week 4. Total scores range from 0 to 24. Higher scores mean worse severity of depressive symptoms.)
- Professional Quality of Life(From baseline to week 2 and week 4)
- Total Sleep Time(Baseline to through study completion)
研究者
Lois James, Ph.D.
Associate Professor, WSU College of Nursing
Fisher Wallace Laboratories