Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577636
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEA_PTSD
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 reprocessing 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
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 reprocessing 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None