Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Feasibility of Cranial Electrotherapy Stimulation
研究概览
简要总结
The goal of this study is to test whether active duty firefighters find it possible and suitable to do cranial electrotherapy stimulation (CES) at home, and test whether CES influences measures of depression and posttraumatic stress. The main questions it aims to answer are:
- is CES feasible and acceptable in a population of firefighters, and
- does CES changes symptoms of posttraumatic stress and depression as well as feelings of anxiety, and fatigue in firefighters.
Participants will
- complete four weeks of CES at home, and
- complete daily assessments of affect and fatigue, and
- complete self-reported symptoms of depression and posttraumatic stress before and after four weeks of CES at home Participants maybe asked to
- complete an MRI scan before and after four weeks of CES at, and
- wear a device to measure their heart rate and sleep quality.
详细描述
Despite an urgent need for interventions that can prevent the development of posttraumatic stress disorder (PTSD) in firefighter first responders who, due to the nature of their occupation, are at ultrahigh risk for PTSD and its profound consequences, current preventative approaches suffer from low rates of efficacy or difficulties with implementation. Cranial electrotherapy stimulation (CES), a noninvasive brain stimulation technique that is FDA approved for treatment of anxiety, insomnia, and depression, offers substantial promise as a proactive preventative intervention for PTSD because of its hypothesized ability to reestablish homeostasis, a process that becomes dysregulated in individuals who develop PTSD. The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct Centers of Biomedical Research Excellence to test whether four weeks of CES is feasible and acceptable in firefighters as well as obtain early signal of CES efficacy to change subjective and objective indices of homeostatic functioning to allow a long-term collaboration with the ultimate goal to develop a safe, effective, and easily deployable intervention to prevent PTSD in first responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active duty firefighter in Rhode Island, USA;
- •Age between 18 and 56 years old;
- •Be in good medical health or, if having chronic medical conditions, these conditions needed to be stable;
- •Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent.
排除标准
- •MRI and CES-related contraindications, e.g., implanted metallic device or substances including pacemakers, cochlear implant, metallic tattoos, claustrophobia, pregnancy or planning to become pregnant during the study duration and nursing;
- •Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery;
- •Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months;
- •Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization;
- •Current moderate or severe alcohol or other substance abuse (excluding nicotine);
- •Major or unstable medical illness requiring further investigation or treatment.
研究组 & 干预措施
Alpha-Stim AID cranial electrotherapy stimulation
Four-week course of noninvasive cranial electrotherapy stimulation.
干预措施: Alpha-Stim AID cranial electrotherapy stimulation (Device)
结局指标
主要结局
Feasibility of Cranial Electrotherapy Stimulation
时间窗: During four weeks of cranial electrotherapy stimulation at-home use
Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed).
Acceptability of Cranial Electrotherapy Stimulation
时间窗: During four weeks of cranial electrotherapy stimulation
Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks
次要结局
- Intensity of Feelings of Fatigue(Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported)
- Intensity of Feelings of Anxiety(Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported)
- Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)(Post four weeks of cranial electrotherapy stimulation)
- Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)(post four weeks of cranial electrotherapy stimulation.)
- Intensity of Feelings of Fatigue(Daily throughout four weeks of cranial electrotherapy stimulation)
- Intensity of Feelings of Anxiety(Daily throughout four weeks of cranial electrotherapy stimulation)