Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving deep sedation leading to loss of responsiveness, designed to elicit dream reports upon emergence (Dream Protocol), and/or (2) light sedation without loss of responsiveness, designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) (Non-Dream Protocol). The investigators will then investigate whether the deep-sedation Dream Condition is associated with a larger reduction in PTSD symptoms than the light-sedation Non-Dream Condition.
详细描述
GENERAL BACKGROUND
Post-traumatic stress disorder (PTSD) affects millions of Americans, and it can make everyday life very challenging. PTSD is characterized by recurrent distressing memories and nightmares, flashbacks, hyperarousal, and avoidance of things that remind individuals of their traumatic event. Nightmares reflect impaired emotion regulation occurring during sleep. There is evidence that therapeutic applications of dreaming may help target nightmares and other PTSD symptoms because dreaming is involved in memory (re)processing and emotion regulation. There is preliminary evidence that dreaming during anesthesia may reduce symptoms of PTSD. However, larger studies are needed to systematically test this.
AIM AND HYPOTHESES
The aim of this study is to test the efficacy of anesthesia-induced dreaming for PTSD in a (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD.
STUDY DESIGN
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind, sham-controlled RCT
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject will be eligible for inclusion when all of the following criteria are met:
- •Male or female, 18 to 70 years of age
- •Able to read, understand, and provide written, dated informed consent prior to screening.
- •Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
- •Meet the threshold of CAPS-5 score of >20 during screening.
- •In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
- •If female, a status of non-childbearing potential or use of an acceptable form of birth control
- •Body mass index between 17-35 kg/m2.
排除标准
- •A potential participant will NOT be eligible for participation if any of the following criteria are met:
- •Female who is pregnant or breastfeeding.
- •Total CAPS-5 score ≤20 at either the screening.
- •Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (>12 months) time frames.
- •Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
- •History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- •History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
- •Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
- •In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
- •A neurological disorder
- •A cardiovascular disorder
- •A pulmonary/respiratory disorder
- •Clinically significant liver disease
- •Clinically significant kidney disease
- •Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher
- •An endocrine disorder
- •Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.
- •If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).
- •Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.
研究组 & 干预措施
Dream Experiences Group
This group (n=21) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports.
干预措施: Propofol anesthesia (Procedure)
Non-Dream Experiences Group
This Group (n=21) will be subjected to a light sedation without loss of responsiveness protocol, designed to elicit non-dream experiential reports while responsive.
干预措施: Propofol anesthesia (Procedure)
Open-label anesthesia protocol
All participants (n = 15) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports AND to a light sedation without loss of responsiveness protocol intended to elicit non-dream experiential reports while responsive.
干预措施: Propofol anesthesia (Procedure)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: 1 month post-intervention
The CAPS-5 is a structured interview that is considered the gold standard for assessing post-traumatic stress disorder (PTSD). The CAPS-5 is designed to assess the 20 symptoms of PTSD as defined by the DSM-5, as well as the impact of these symptoms on social and occupational functioning. The CAPS-5 includes 20 items corresponding to the DSM-5 criteria for PTSD. Each item is rated for both frequency and intensity, with a 5-point scale (0-4) for each dimension. The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. A score of \>20 points indicates clinically significant PTSD symptoms. Superiority of "Dream Experiences Group" over "Non-Dream Experiences Group" will be demonstrated by a statistically significant greater decrease in the CAPS-5 when comparing pre-anesthesia scores to post-anesthesia scores.
次要结局
- Number of Participants With Clinical Response(1 month post-intervention)
- Number of Participants With Remission(1 month post-intervention)
- PTSD Checklist for DSM-5 (PCL-5)(1 month post-intervention)
研究者
Boris D. Heifets
Associate Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University