Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorStanford University
About this trial
The goal of this study is to test whether anesthesia-induced experiences can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (Phase II) in a non-surgical setting. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving a sedation protocol associated with dream experiences upon emergence (Dream Condition), and/or (2) a sedation protocol associated with non-dream experiences (Non-Dream Condition). The investigators will then investigate whether the Dream Condition is associated with a larger reduction in PTSD symptoms than the Non-Dream Condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 Quick Structured Clinical Interview for DSM Disorders (QuickSCID-5).
Meet the threshold of CAPS-5 score of >20 during screening.
Disqualifiers
Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
Female who is pregnant or breastfeeding.
Female with a positive pregnancy test on the day of, and prior to, the anesthesia session.
Total CAPS-5 score ≤20 at either the screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Propofol
DrugPropofol will be administered intravenously under EEG guidance according to the study-specific sedation protocol. The propofol administration parameters will vary according to the assigned study condition, with protocols designed to elicit either dream experiences or non-dream experiences.
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Dream Experiences GroupExperimental treatment 1 intervention
Group B: Non-Dream Experiences GroupActive comparator 1 intervention
Group C: Open-label anesthesia protocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Time frame
1 month post-interventionSecondary outcomes
1
Proportion of Participants With Clinical Response
Clinical response is defined as a reduction of ≥15 points (or ≥30% - 50%) in the CAPS-5 total severity score from baseline (pre-anesthesia) to Day +30 post-anesthesia, comparing the Dream versus No-Dream groups.
Time frame
1 month post-intervention2
Proportion of Participants With Remission
Remission is defined as obtaining a score of ≤20 points on the CAPS-5, comparing the Dream versus No-Dream groups.
Time frame
1 month post-intervention3
Change in the PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report measure designed to assess the 20 symptoms of post-traumatic stress disorder (PTSD) as defined by the DSM-5. Includes 20 items that correspond directly to the DSM-5 criteria for PTSD. Each item is rated on a 5-point Likert scale from 0 (Not at all) to 4 (Extremely), indicating how much the symptom has bothered the individual in the past week/month. The total score can range from 0 to 80, with higher scores indicating more severe PTSD symptoms. A score of 31-33 or higher is considered indicative of symptomatic PTSD. A reduction in PTSD symptoms will be indicated by a change in the PCL-5 total score from baseline (pre-anesthesia) to post-anesthesia, comparing the Dream versus No-Dream groups.
Time frame
1 month post-intervention4
Treatment Response Assessed Using the PTSD Checklist for DSM-5 (PCL-5)
Proportion of participants achieving a reduction of ≥30% in the PCL-5 total score from baseline to Day +30, comparing the Dream versus No-Dream groups.
Time frame
1 month post-interventionSponsors and contacts
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Stanford University
Lead sponsor
Tiny Blue Dot Foundation
Collaborator
Advanced Research Projects Agency for Health (ARPA-H)
Collaborator
Source ClinicalTrials.gov