Clinical trial NCT06577636: Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
Official title: Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: PTSD
Post-traumatic Stress Disorder
Keywords: anesthesia
propofol
PTSD
post-traumatic stress disorder
dreaming
dreams
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Tiny Blue Dot Foundation
First posted: 2024-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of participants will be randomized to either (a) Dream group, or (b) No-Dream group.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the efficacy of anesthesia-induced dreaming for PTSD in a double-blind, randomized controlled trial in a non-surgical setting (Phase II). The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Half of the participants will be randomly allocated to a Dream Group, while the other half will be in the No-Dream group.

Detailed description: 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 double-blind, randomized controlled trial in a non-surgical setting (Phase II). The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD.

STUDY DESIGN

Randomization: Double-blind, sham-controlled RCT

Sample Size: 42 (21 in Dream group, 21 in No-Dream group)

Variables: Outcome variables include: (1) Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); (2) PTSD Checklist for DSM-5 (PCL-5)

STUDY PROCEDURES AND MEASURES

This research study is expected to take approximately 3 months to complete (per participant). During this time, participants will make 1 screening visit via zoom and 1 in-person screening visit at Stanford Hospital. Participants will also complete daily assessments of sleep quality and dream experiences 2 weeks before and 2 weeks after the anesthesia session. Participants will fill in pre-anesthesia and post-anesthesia questionnaires measuring mental health and well-being and, complete follow-up measures 1 week, 2 weeks, 1 month, and 3 months after the anesthesia session. During the anesthesia session, participants will undergo EEG-guided infusion of propofol targeted to reach a Dream or No-Dream state. Immediately upon emerging from anesthesia, participants will be interviewed using the modified Brice questionnaire and their responses audio recorded.

Eligibility criteria: Inclusion Criteria:

A subject will be eligible for inclusion when all of the following criteria are met:

1. Male or female, 18 to 70 years of age
2. Able to read, understand, and provide written, dated informed consent prior to screening.
3. 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).
4. Meet the threshold of CAPS-5 score of \>20 during screening.
5. 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.
6. If female, a status of non-childbearing potential or use of an acceptable form of birth control
7. Body mass index between 17-32 kg/m2.

Exclusion Criteria:

A potential participant will NOT be eligible for participation if any of the following criteria are met:

1. Female who is pregnant or breastfeeding.
2. Total CAPS-5 score ≤20 at either the screening.
3. 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.
4. 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)
5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
6. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
7. 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.
8. 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.
9. A neurological disorder
10. A cardiovascular disorder
11. A pulmonary/respiratory disorder
12. Clinically significant liver disease
13. Clinically significant kidney disease
14. 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
15. An endocrine disorder
16. 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.
17. 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).
18. 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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: 1 month post-intervention
measure: Number of Participants With Remission
timeFrame: 1 month post-intervention
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 1 month post-intervention
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Boris D Heifets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hack LM, Sikka P, Zhou K, Kawai M, Chow HS, Heifets B. Reduction in Trauma-Related Symptoms After Anesthetic-Induced Intra-Operative Dreaming. Am J Psychiatry. 2024 Jun 1;181(6):563-564. doi: 10.1176/appi.ajp.20230698. Epub 2024 Mar 13. No abstract available.
citation: Chow HS, Hack LM, Kawai M, Heifets BD. Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. A A Pract. 2022 Aug 10;16(8):e01613. doi: 10.1213/XAA.0000000000001613. eCollection 2022 Aug 1.
citation: Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.