Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation.
This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years
详细描述
The study examines the effect of the Apollo wearable on its users after undergoing MDMA-assisted psychotherapy. There will be no study specific modification to the MDMA-assisted psychotherapy that participants receive. All study participants will have previously consented to MAPS MDMA-assisted psychotherapy for PTSD clinical trial before enrolling in this protocol. Once they have been identified as people who have been consented to the MAPS trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly.
Participants will receive the Apollo wearable device via mail upon consenting to participate in this study. They will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the Apollo device in their everyday life following MDMA-assisted psychotherapy.
Participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study.
Please note: this study is not affiliated with the MAPS organization who is running the MDMA-assisted psychotherapy research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age 18 or over
- •Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
- •completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
- •enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out
排除标准
- •Unable to give adequate informed consent
- •Have any current problem which, in the opinion of the investigator might interfere with participation
- •Are unable to complete questionnaires written in English
研究组 & 干预措施
MDMA-Assisted Psychotherapy Participants
Participants who have completed the MDMA-Assisted Psychotherapy and consented to be part of this study will use an 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 (Device)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Through study completion, an average of two years
PTSD Checklist for DSM-5 (PCL-5) will be used to measure symptoms of PTSD.
Beck Depression Inventory II (BDI-II)
时间窗: Through study completion, an average of two years
Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.
次要结局
- Alcohol Use Disorders Identification Test (AUDIT)(Through study completion, an average of two years)
- World Health Organization Health and Work Performance Questionnaire (HPQ Short form)(Through study completion, an average of two years)
- Drug Use Disorders Identification Test (DUDIT)(Through study completion, an average of two years)
- Chronic Pain Grade Scale (CPGS)(Through study completion, an average of two years)