Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in symptom ratings from pre- to post-
研究概览
简要总结
Involuntary stress reactions including hyper-reactivity and dissociation are key diagnostic features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention, Tuned Vibroacoustic Stimulation (TVS), capitalizing on a preserved neurocircuitry for sympathetic and parasympathetic system activity can be used to modify arousal responses, overriding otherwise prepotent negative stress reactions.
PTSD has been characterized by dysregulated responses to stress as a result of severe acute or chronic trauma resulting in significantly impaired functioning, quality of life, and morbidity/mortality. Physiologically, PTSD severity has been associated with elevated sympathetic tone and low heart rate variability suggesting that parasympathetic tone is suppressed. Lower heart rate variability specifically, as a measure of parasympathetic tone, is closely associated with impaired performance and resilience. In our first study (in review), we showed that in some individuals, TVS is associated with increased heart rate variability and performance under stress along with reduced subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD.
N=100 individuals with mild-moderate PTSD (as assessed by PCL-5/CAP5), at least half of which are military Veterans, will be assessed physiologically during active interventions. Mechanisms of attentional focus on cognitive and emotional stimuli will be assessed. Participants will also have a real-world intervention to determine if TVS helps alleviate stress, symptoms, and medication burden in the real world when stress has been identified. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology.
详细描述
This protocol will examine and elucidate a mechanistic model for tuned vibroacoustic stimulation (TVS), an exteroceptive cue that has been shown to reduce subjective and physiological indicators of stress and increase behavioral performance in healthy subjects. In this study, we will test whether TVS can reduce subjective and physiological signs of stress, improve performance, alleviate symptoms, and reduce medication burden in adults with post-traumatic stress disorder (PTSD). This protocol will also examine whether software that cues TVS in response to biological stress markers helps users detect, regulate, and develop long-term resilience to stress outside of the laboratory.
Aim 1: Examine how TVS alters calmness and stress markers. Our overall hypothesis is that TVS, in combination with some other task, increases performance on that task by decreasing stress and increasing emotion regulation.
Hypothesis 1: TVS during an attention task will lead to decreased GSR, increased HRV, and increases in prefrontal gamma and theta band EEG, along with improved behavioral performance on a focused attention, working memory and emotional information processing task. TVS will also reduce subjective stress levels.
Aim 2: Examine the extent to which software, which monitors real time biological stress markers of users, and in response, automatically signals wearable hardware to deliver TVS when user is stressed, will be able to help users detect, regulate, and develop long-term resilience to stress outside the laboratory for two weeks.
Hypothesis 2.1: Evaluate whether subjects with PTSD in the real world will use our software to detect and alert them of stress dynamically and if this is associated with stress regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
On-demand intervention was provided on only some physiologically detected stress events
入排标准
- 年龄范围
- 18 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female who are 18 - 58 years of age
- •For PTSD participants, must meet current DSM-V criteria for PTSD based on the PCL-5 (Score > 33) and MINI PTSD Scale (administered in lab).
- •If taking psychoactive medications, must be on a stable regimen for 3 weeks or more.
- •Must have a functioning smartphone with Apple iOS or Android
排除标准
- •Refusal or inability to provide informed consent
- •Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
- •Current or recent (within the last 8 weeks) physically aggressive behavior.
- •Meets current DSM-V criteria for substance dependence ((serious substance use in DSM-V parlance, not in remission) except nicotine and caffeine), traumatic brain injury, bipolar affective disorder, schizophrenia or any psychotic disorder.
- •Has unstable or serious medical illness, including history of stroke, epileptic disorder, or unstable cardiac disease, that would interfere with participation in treatment.
- •Taking medications that could affect thinking which must be taken on the day of testing, or dependence on psychoactive drugs (prescription or non-prescription) that could affect thinking. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Examples of drugs which could affect performance on cognitive tasks or the administered physiological measures include beta-blockers, benzodiazepines, antipsychotics, stimulants (except for treatment of ADD/ADHD), narcotics, and anti--Parkinsonian drugs.
- •Severe cognitive impairment or severe trauma
- •Unable to comprehend or communicate in English, and unable to complete questionnaires written in English.
- •Having any eye problems or difficulties in corrected vision or hearing, including poor color vision
- •Having a North American Adult Reading Test (NAART) equivalent FSIQ < 85
- •Severe or poorly controlled concurrent medical disorders or require medication that could cause negative thinking
- •Specific Exclusions for acoustic vibration include:
- •- Any electrical implant (pacemaker, vagus nerve stimulator, etc).
结局指标
主要结局
Change in symptom ratings from pre- to post-
时间窗: Change in symptom ratings over the approximately two weeks of the acute intervention (pre- to post- assessment)
Subjective affect / symptom ratings will be obtained daily. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.
Change in resting Heart Rate Variability (HRV) from pre- to post-
时间窗: HRV will be measured during the entire study which is two weeks
HRV, an index of parasympathetic reactivity, will be obtained throughout the day during the study. Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.
次要结局
- prefrontal gamma band EEG during information processing tasks (composite)(EEG will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits.)
- Change in Heart Rate Variability (HRV) during information processing tasks (composite)(HRV will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits.)
- Galvanic skin response (GSR) during information processing tasks (composite)(GSR will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits.)
研究者
Greg Siegle
Associate Professor
University of Pittsburgh