Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
NCT Number: NCT06577636
Acronym: IDEA_PTSD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: PTSD|Post-traumatic Stress Disorder
Interventions: PROCEDURE: Propofol anesthesia
Sponsor: Stanford University
Collaborators: Tiny Blue Dot Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-12
Locations: Stanford University, Stanford, California, 94305, United States

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.

Primary Outcome Measures: 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 group" over "No-Dream group" will be demonstrated by a statistically significant greater decrease in the CAPS-5 when comparing pre-anesthesia scores to post-anesthesia scores., 1 month post-intervention
Secondary Outcome Measures: Number of Participants With Clinical Response, Clinical response is defined as a reduction of ≥15 points (or ≥30% - 50%) in the score of CAPS-5 in the Dream Group, comparing baseline pre-anesthesia scores to post-anesthesia scores., 1 month post-intervention|Number of Participants With Remission, Remission is defined as obtaining a score of ≤20 points on the CAPS-5 in the Dream Group post-intervention., 1 month post-intervention|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. Superiority of the Dream vs No-Dream group will be demonstrated by a reduction of ≥30% - 50% in the self-reported PTSD symptoms, as measured with the PCL-5, comparing baseline pre-anesthesia scores to post-anesthesia scores., 1 month post-intervention