Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Acceptability via Credibility Scale
研究概览
简要总结
The proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data regarding biological signatures will also be collected.
详细描述
Evaluation of Apollo requires a stepwise process in which initial aims are geared towards identifying biological signatures versus diagnosing, treating, mitigating or curing any conditions. Towards the end of identifying potential biological signatures, we hypothesize the following. 1) Participants who use the Apollo will have an attenuated physiological stress response as measured by improved heart rate variability (HRV) compared to baseline. 2) Participants who use Apollo will have attenuated perceived psychological stress measured by lower scores on psychological correlates of acute stress when compared to baseline
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans eligible to receive care by a VA provider
- •History of at least one deployment in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND)
- •Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
- •Willingness to wear the Apollo daily and to comply with study protocol
- •Android or Apple smart phone on which the participant can download the Apollo mobile app
- •Age between 18 and 65
- •Ability to provide informed consent
排除标准
- •Inability to adequately respond to questions regarding the informed consent procedure
- •Currently involved in the criminal justice system as a prisoner or ward of the state
- •Current (past month) alcohol or substance abuse or dependence
- •Lifetime history of bipolar disorder, psychosis, or delusional disorders
- •Lifetime history of oppositional defiant disorder or anti-social personality disorder
- •Recent medication changes in the past 4 weeks
- •A current beta blocker prescription (other than prazosin)
- •Active untreated visual impairment
研究组 & 干预措施
Single Arm- Apollo Wearable System
Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable) as this is where the TVS seems to be most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature.10-14 The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.
干预措施: Apollo Wearable System (Device)
结局指标
主要结局
Acceptability via Credibility Scale
时间窗: 6 +/- 2 weeks
The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.
Acceptability via Expectancy Scale
时间窗: 6 +/- 2 weeks
The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.
Acceptability via Client Satisfaction Questionnaire (CSQ)
时间窗: 6 +/- 2 weeks
Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.
Feasibility via Client Satisfaction Questionnaire (CSQ)
时间窗: 6 +/- 2 weeks
Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.
Acceptability via Narrative Evaluation of Intervention Interview (NEII)
时间窗: 6 +/- 2 weeks
Narrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention.
Feasibility via Credibility Scale
时间窗: 6 +/- 2 weeks
The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.
Feasibility via Narrative Evaluation of Intervention Interview (NEII)
时间窗: 6 +/- 2 weeks
Feasibility will be aNarrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention. ssessed using the Credibility/Expectancy Scales, Client Satisfaction Questionnaire (CSQ), and the Narrative Evaluation of Intervention Interview (NEII).
Feasibility via via Expectancy Scale
时间窗: 6 +/- 2 weeks
The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.
次要结局
未报告次要终点
研究者
Lisa Brenner
Director, Rocky Mountain Mental Illness Research, Education, and Clinical Center
VA Eastern Colorado Health Care System