Novel Mental Health Therapies to Improve Military Readiness
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- David Moss
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Beck Anxiety Inventory (BAI)
研究概览
简要总结
To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.
详细描述
Anxiety disorders are diverse. The Veterans Administration diagnostic code options for anxiety are Post-Traumatic Stress Disorder (PTSD), Generalized Anxiety Disorder (GAD), obsessive- compulsive disorder (OCD), Other Specified Anxiety Disorder, phobias and Social Anxiety Disorder, and panic disorder and/or agoraphobia. In the US Military, anxiety disorders are increasing in prevalence.
According to one DoD report, by 2012 anxiety disorders made up more medical encounters than any other mental disorder and was fourth in overall encounter categories including non-mental health related injuries and illnesses (Anxiety Disorders Active Component).
Traditional mental health therapies and active-duty military readiness are often mutually exclusive due to habit-forming and significant physical and mental adverse side effects resulting from standard mental health therapies. In veterans, while work readiness is less of an issue, traditional mental health therapies affect activities of daily living and overall quality of life.
Nonpharmacological approaches to mental health therapy in the military health system are therefore relevant and timely (Bravo).
Cranial Electrotherapy Stimulation (CES): Also known by the proprietary name Alpha-Stim, cranial electrotherapy stimulation is a noninvasive neuromodulation treatment commonly used to mitigate anxiety, posttraumatic stress, insomnia, and depression. The device is FDA cleared for the treatment of anxiety, insomnia, depression, and acute post-traumatic and chronic pain.
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
- Double (Participant, Investigator)
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
- •**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Active Duty and DoD Beneficiaries aged 18 or older
- •Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher
排除标准
- •Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review.
- •Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine.
- •Subjects taking any seizure medications (ex: Dilantin)
- •Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum.
- •Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment.
- •Subjects who have started, altered, or discontinued use of any anti-depressant or anxiolytic in the past four weeks (including any medication in the following classes; selective serotonin reuptake inhibitors [SSRI], serotonin and norepinephrine reuptake inhibitors [SnRI], Wellbutrin, beta blockers specifically taken for anxiety, monoamine oxidase inhibitors [MAOI], tricyclic antidepressants [TCA], benzodiazepenes).
- •Pregnancy
- •Current or previous use of a CES device.
- •Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or past 3 months).
- •Psychotherapy for anxiety based on exposure therapy (current or past 6 weeks)
- •Seizure disorder (current or history). History of febrile childhood seizures is allowed.
- •Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (CSSRS).
- •Known cardiac arrythmias
- •Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.
研究组 & 干预措施
Group 2: Sham CES
Sham CES treatment at home 40 minutes daily for 6 weeks
干预措施: Sham Comparator (Device)
Group 1: Active CES
Active CES treatment at home 40 minutes daily for 6 weeks
干预措施: Experimental: Alpha-Stim 100 (Device)
结局指标
主要结局
Beck Anxiety Inventory (BAI)
时间窗: Visit 8 (Week 10)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. BAI will be obtained.
Heart Rate Variability (HRV)
时间窗: Visit 8 (Week 10)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Visit 8 (Week 10)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. HAM-A will be obtained.
Vagal Efficiency (VE)
时间窗: Visit 8 (Week 10)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone
Beck Anxiety Inventory (BAI)
时间窗: Visit 1 (Week 0)
BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. Baseline BAI will be obtained.
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Visit 1 (Week 0)
HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. Baseline HAM-A will be obtained.
Heart Rate Variability (HRV)
时间窗: Visit 1 (Week 0)
Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)
Vagal Efficiency (VE)
时间窗: Visit 1 (Week 0)
Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone.
次要结局
未报告次要终点
研究者
David Moss
Doctor/Principal Investigator
Mike O'Callaghan Military Hospital