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PTSDPhase 2IDEA_PTSDNCT06577636

Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder

A Phase 2 study testing Propofol in people with PTSD and Post-traumatic Stress Disorder, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PTSD, Post-traumatic Stress Disorder
What is being tested?
Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
21 Jul 2025to May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Quick Structured Clinical Interview for DSM Disorders (QuickSCID-5).
  • Meet the threshold of CAPS-5 score of >20 during screening.
  • Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least 4 weeks prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject's participation in the study.
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  • Concurrent antidepressant therapy (e.g. SSRI or SNRI) will be allowed if the therapy has been stable for at least 4 weeks prior to screening, and if it is expected to remain stable during the course of the subject's participation in the study.
  • 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, or III. ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression, anxiety or PTSD) will be included.
  • 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.

Who cannot join

  • A potential participant will NOT be eligible for participation if any of the following criteria are met:
  • 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.
  • Current diagnosis or a recent history (within 2 years) of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the QuickSCID-5, or Alcohol Use Disorder rated "moderate" or "severe" per QuickSCID-5 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.
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  • History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by QuickSCID-5 interview.
  • History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
  • Any DSM-5 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.
  • Has abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA Class III or higher.
  • Has a positive urine drug screen on the day of the anesthesia session.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Boris D Heifets, MD, PhD contact

(669) 241 6118

anesthesiastudy@stanford.edu

Pilleriin Sikka, PhD contact

6506808801

sikka@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Stanford, California, 94305

    Boris D Heifets, MD, PhD, 917 620 4241, bheifets@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled 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.

Read the 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 (1) open-label trial (Phase I) and (2) a single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded clinical 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

Design:

Phase I : Open-label study Phase II: Double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (RCT)

Sample Size:

Phase I: N = 15 Phase II: N = 42 (21 in Dream Condition, 21 in Non-Dream Condition)

Variables:

Phase I and II: 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 four months to complete (per participant). During this time, participants will make two pre-screening visits via Zoom as well as one screening visit via Zoom and one in-person screening visit at Stanford Hospital. Participants will also complete daily assessments of sleep quality and dream experiences 2 weeks before and 2-4 weeks after the anesthesia session. In Phase I, participants will also wear the Muse headband to measure sleep quantity and quality daily for 2 weeks before and 2 weeks after the intervention session. In Phase II, participants will wear a GGX EEG Patch to measure sleep quantity and quality for 2 weeks before and 4 weeks after the intervention session. Participants will fill in pre-anesthesia and post-anesthesia questionnaires measuring mental health and well-being and, complete follow-up measures 1 day, 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.

In Phase I, all participants will undergo at least two sessions: (1) a sedation protocol intended to elicit dream reports (Dream Condition); and (ii) a sedation protocol designed to elicit non-dream experiential reports (Non-Dream Condition).

In Phase II, participants will be randomized into either the Dream or Non-Dream Group, undergoing either the protocol designed to elicit dream experiences or non-dream experiences, respectively.

Immediately upon emerging from anesthesia, participants will be interviewed using the modified Brice questionnaire and their responses audio- and video-recorded.

Being tested
Propofol
Keywords
anesthesia, propofol, PTSD, post-traumatic stress disorder, dreaming, dreams
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    Propofol 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.

Study groups in NCT06577636
Study groupRoleWhat they receive
Dream Experiences GroupExperimentalThis group (n=21) will undergo a sedation protocol intended to elicit dream experiences.
Receives: Drug: Propofol
Non-Dream Experiences GroupActive comparatorThis Group (n=21) will undergo a sedation protocol designed to elicit non-dream experiences.
Receives: Drug: Propofol
Open-label anesthesia protocolExperimentalAll participants (n = 15) will undergo both an EEG-guided sedation protocol intended to elicit dream experiences and a sedation protocol intended to elicit non-dream experiences.
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month post-intervention

Secondary outcomes (4)

  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.

    Measured: 1 month post-intervention

  2. 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.

    Measured: 1 month post-intervention

  3. 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.

    Measured: 1 month post-intervention

  4. 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.

    Measured: 1 month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start21 Jul 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of participants will be randomized to either (a) Dream experiences group, or (b) Non-Dream experiences group.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577636
Sponsor's protocol ID
76919; 88897
Acronym
IDEA_PTSD
Status last verified
Sep 2026
First submitted
27 Aug 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Identifiers might be removed from identifiable private information and/or identifiable specimens and, after such removal, the information and/or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant. The results of this research study may be presented at scientific or medical meetings or published in scientific journals without disclosing the identify of the participants (unless there is a separate consent from participants to reveal their identity).

Publications

  • Sikka P, Hu S, Heifets BD. Dreaming during anaesthesia: a scoping review. Br J Anaesth. 2026 Aug;137(2):506-524. doi: 10.1016/j.bja.2026.05.002. Epub 2026 Jun 11.

    PubMed 42270528

  • Sikka P, Ngo MC, Hu S, Wilkerson TB, Shull M, Imbordino K, Ishii T, Kawai M, Deverett B, Chow HS, Heifets BD. Feasibility of a Multicomponent Protocol to Promote Dreaming during Surgical Anesthesia. Anesthesiology. 2026 Jul 1;145(1):21-36. doi: 10.1097/ALN.0000000000005968. Epub 2026 Feb 3.

    PubMed 41632715

  • 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.

    PubMed 38476046

  • 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.

    PubMed 35952341

  • 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.

    PubMed 28493729

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propofol in people with PTSD and Post-traumatic Stress Disorder, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boris D Heifets, MD, PhD ((669) 241 6118, anesthesiastudy@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: 1 month post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06577636, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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