ClinicalTrials.gg
RecruitingNCT07840417Updated Oct 5, 2026

Deep Brain Reorienting for Posttraumatic Stress Disorder

An interventional study of Deep Brain Reorienting and Treatment as Usual (TAU) in Posttraumatic Stress Disorder (PTSD) and Posttraumatic Stress Symptom, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Updated Oct 5, 2026Eligibility revisedInterventions changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 125 studies in Stress Disorders, Post-Traumatic with a site in Canada — 32 open to participants now, 40 under way, 2 of them phase 3. Stress Disorders, Post-Traumatic · Canada.

Planned enrollment
58th of 111
50 · median 54
Started
2026
with 14 others
No phase
82 of 125
19 open now
Primary completion
2028-01
later than 27 of 39 live
Registered
124th of 125
by date

Among the 125 studies in Stress Disorders, Post-Traumatic with a site in Canada, this one is the 58th largest by planned enrollment of the 111 interventional ones that give a count, is one of 15 that started in 2026, is one of 82 with no phase, reaches primary completion later than 27 of the 39 other live ones, and was the 124th registered.

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 50 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Open to participants now

32 of the 125 studies in Stress Disorders, Post-Traumatic with a site in Canada are open now.

All 32 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 205 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →
Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 125 studies in Stress Disorders, Post-Traumatic with a site in Canada, or all of them as a file.
02

Study summary

The goal of this clinical trial is to learn if Deep Brain Reorienting (DBR) works to treat posttraumatic stress disorder (PTSD) symptoms in military veterans. The main questions it aims to answer are:

  • Does DBR lower PTSD symptoms compared with treatment as usual?
  • Do PTSD symptoms stay lower three months after treatment?

Researchers will compare waitlist to see if DBR works to treat PTSD.

Participants will:

  • Receive eight DBR sessions, each lasting about 50 minutes
  • Answer questions before and after treatment and 3 months later
  • Complete short questionnaires before and after each session
  • Complete an interview about their experience of DBR
03

Conditions studied

  • Posttraumatic Stress Disorder (PTSD)
  • Posttraumatic Stress Symptom

Keywords

  • posttraumatic disorder
  • PTSD
  • Deep Brain Reorienting
  • trauma-focused therapy
  • RCT
04

Who can participate

The criteria were revised on the registry on Oct 5, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Stream 1: Military Veterans receiving the DBR Intervention:

Inclusion criteria

Inclusion Criteria

  • 18 to 65 years old
  • Current or former military member / Veteran (for Stream 1 only)
  • PTSD diagnosis determined via the CAPS-5
  • If on psychiatric medications: stable ≥ 4 weeks
  • Fluent in English
  • Ability to provide and participate in therapy sessions
  • Able to benefit from short-term therapy, as determined by study assessment

Exclusion criteria

Exclusion Criteria

  • High-risk clinical state (e.g., suicidal or homicidal intent; substance withdrawal) requiring acute intervention.
  • History of moderate to severe head or brain injury leading to impaired functioning (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident assessed retrospectively by participant; sustained loss of consciousness leading to impaired functioning)
  • Cognitive impairment limiting
  • Significant untreated medical illness
  • History of neurological disorder, pervasive developmental disorder, bipolar or psychotic disorder
  • Alcohol/substance use problems within the last 3 months requiring medical withdrawal or likely to interfere with therapy.
  • Degree of mental distress that is unlikely to benefit from a short-term therapy (for our participant's well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).
  • Any condition that, in the clinical opinion of study psychiatrists or clinicians, would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homeless, ongoing psychosocial crisis, etc).

Other considerations:

Participants will be asked not to start any new PTSD treatments (medications or psychotherapy) 4 weeks prior to study enrollment and until study participation is complete.

If already taking psychiatric medications, doses must be stable for at least 4 weeks prior to enrolling in the study, and remain stable until study completion.

Participants in DBR stream must be able and willing to pause other trauma-focused psychotherapies (e.g., CPT, EMDR, exposure therapy) while receiving DBR in the study. Non-trauma focused therapies (e.g. CBT) or supportive talk with a therapist may continue.

We are currently actively recruiting participants for Stream 1 only, exclusively military veterans.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Stream 1: Military Veterans - DBR Group

    Military veterans who are randomized to receive eight weekly sessions of Deep Brain Reorienting (DBR).

    Behavioral: Deep Brain Reorienting

  • Active comparator
    Stream 1: Military Veterans - Waitlist/Treatment as Usual

    Military veterans are randomized to continue treatment as usual during an eight-week waiting period. Following completion of the waitlist and follow-up assessments, eligible participants may be offered DBR.

    Behavioral: Treatment as Usual (TAU)

Interventions

  • BehavioralDeep Brain Reorienting

    Deep Brain Reorienting (DBR) is a neuroscientifically informed psychotherapy targeting the midbrain-brainstem sequence of orienting tension, shock, and affective response encoded during traumatic events. DBR interventions guide participants through these subcortically mediated survival-oriented responses to facilitate integration and resolution. In contrast to other guideline-based trauma-focused psychotherapies, it does not require verbal exploration of traumatic memories. Instead, it focuses on the response to trauma reminders at the level of the brainstem orienting response and Innate Alarm System. DBR will be administered by certified, experienced trauma clinicians, such as psychiatrists and psychotherapists. Each DBR session will include the following: * Identification of orienting tension * Attunement to shock activation * Integration of affective sequences * Resolution of trauma-encoded brainstem orientation patterns

  • BehavioralTreatment as Usual (TAU)

    This intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.

06

What researchers measure

Primary outcomes

  1. Change From Initial Assessment in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the CAPS-5

    The Clinician-Administered PTSD Scale-5 (CAPS-5) is a clinician-rated measure of PTSD symptom severity. Each item is rated from 0 (absent) to 4 (extreme/incapacitating) and summed to produce a total score ranging from 0 to 80. Higher scores indicate more severe PTSD symptoms.

    Time frame: From initial assessment to post-treatment at 8 weeks and the 3-month follow-up

  2. Change From Baseline in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the PCL-5

    The PTSD Checklist for DSM-5 (PCL-5) is a self-reported measure of PTSD symptom severity. Each item is rated from 0 (not at all) to 4 (extremely). The total score ranges from 0 to 80, with higher scores indicating more severe PTSD symptoms.

    Time frame: From baseline to post-treatment at 8 weeks and the 3-month follow-up

  3. Themes Related to Mental Health Professionals' Experiences of Learning Deep Brain Reorienting (DBR), as Identified Through Qualitative Interviews

    Mental health professionals' experiences of learning DBR will be explored through qualitative interviews. This interview will take about 30 to 60 minutes. No numerical score will be generated.

    Time frame: Post DBR training

Secondary outcomes

  1. Change from Baseline in Dissociation Symptoms at 8 Weeks and 3-Month Follow-Up as Assessed by the DES

    The Dissociative Experiences Scale (DES) is a self-report scale for dissociative symptoms. Total scores range from 0 (never) to 100 (always). Higher scores indicate more frequent dissociative symptoms.

    Time frame: From baseline to post-treatment at 8 weeks, and the 3-month follow-up

  2. Change From Initial Assessment in Depression Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the BDI-II

    The Beck Depression Inventory (BDI-II) is a self-report scale measuring depression symptom severity. Total scores range from 0 to 63, with higher scores indicating more severe symptoms.

    Time frame: From initial assessment to post-treatment at 8 weeks and the 3-month follow-up

  3. Change From Baseline in Trauma-related Shame at 8 Weeks and 3-Month Follow-Up as Assessed by the TRSI

    The Trauma-related Shame Inventory (TRSI) is a 24-item self-report questionnaire measuring shame related to traumatic experiences. Each item is scored from 0 (not true of me) to 3 (completely true of me). Total scores range from 0 to 72, with higher scores indicating greater trauma-related shame.

    Time frame: From baseline to post-treatment at 8 weeks and the 3-month follow-up

  4. Change From Baseline in Interoceptive Awareness at 8 Weeks and 3-Month Follow-Up as Assessed by the MAIA-Version 2

    The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) is a 37-item self-report questionnaire measuring awareness of internal bodily sensations. Each item is scored from 0 (never) to 5 (always), with higher scores indicating greater interoceptive awareness.

    Time frame: From baseline to post-treatment at 8 weeks and the 3-month follow-up

  5. Change From Baseline in Physical Symptoms at 8 Weeks and 3-Month Follow-Up as Assessed by the PSS

    The McFarlane's Physical Symptoms Questionnaire (PSS) is a self-report questionnaire that measures physical symptoms experienced in the past month. Each symptom is rated from 0 (none) to 3 (severe), with higher scores indicating more severe physical symptoms.

    Time frame: From baseline to post-treatment at 8 weeks and the 3-month follow-up

  6. Change From Baseline in Emotion Regulation at 8 Weeks and 3-Month Follow-Up as Assessed by the DERS-16

    The Brief Version of the Difficulties in Emotion Regulation Scale (DERS-16) is a self-report questionnaire measuring difficulties with emotion regulation. Each item is scored from 1 (almost never) to 5 (almost always). Total scores range from 16 to 80, with higher scores indicating greater difficulty regulating emotions.

    Time frame: From baseline to post-treatment at 8 weeks and the 3-month follow-up

07

Study locations

1 of 1 sites recruiting
  • Alberta Hospital Edmonton
    Edmonton, Alberta T5Y 6A8, Canada
    Recruiting
    • Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC · Contactow@ualberta.ca · 780-342-5635
    • Lisa Burback (Psychiatrist and Associate Clinical Professor), BSc(Pharm), MD, FRCPC · Contactburback@ualberta.ca
08

References and documents

Publications

  • Gerge A. The utilisation of deep brain reorienting (DBR) in the treatment of two clients with dissociative identity disorder (DID). European Journal of Trauma & Dissociation. 2025 Jul 17:100579.
  • Gerge A. In-depth consultation: Deep brain reorienting (DBR) as a potential tool for transforming countertransference reactions in trauma therapists. European Journal of Trauma & Dissociation. 2024 Sep 1;8(3):100442.
  • Frau C, Corrigan FM. Verbal Abuse, Depersonalization, and the Innate Alarm and Defensive Systems: A Single Case Illustration of Treatment with Deep Brain Reorienting. J Child Adolesc Trauma. 2024 Dec 6;18(1):11-21. doi: 10.1007/s40653-024-00672-z. eCollection 2025 Mar. PubMed 40098781 ↗
  • Corrigan FM, Young H, Christie-Sands J. Deep Brain Reorienting: Understanding the Neuroscience of Trauma, Attachment Wounding, and DBR Psychotherapy. Taylor & Francis; 2024 Dec 30.
  • Corrigan FM, Christie-Sands J. An innate brainstem self-other system involving orienting, affective responding, and polyvalent relational seeking: Some clinical implications for a "Deep Brain Reorienting" trauma psychotherapy approach. Med Hypotheses. 2020 Mar;136:109502. doi: 10.1016/j.mehy.2019.109502. Epub 2019 Nov 18. PubMed 31794877 ↗
  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006 Jan;3(2):77-101.
  • Kearney BE, Corrigan FM, Frewen PA, Nevill S, Harricharan S, Andrews K, Jetly R, McKinnon MC, Lanius RA. A randomized controlled trial of Deep Brain Reorienting: a neuroscientifically guided treatment for post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2240691. doi: 10.1080/20008066.2023.2240691. PubMed 37581275 ↗
  • Panksepp, J. and Trevarthen, C. (2009). The Neuroscience of Emotion. In S. Malloch and C. Trevarthen, Communicative Musicality, pp.105-146. Oxford University Press: New York
  • Panksepp J. Affective Neuroscience: the foundations of human and animal emotions. New York: Oxford University Press; 1998.

Individual participant data

Plan to share: Yes — De-identified participant data (IPD) in this study will be made available to qualified researchers upon reasonable request to the corresponding author, subject to applicable research ethics, institutional, privacy, and data-sharing requirements. Requests will be considered based on the scientific merit and purpose of the proposed use. Data will only be shared where permitted by participant consent and applicable approvals, and a data-sharing agreement may be required. Supporting study documents, such as the study protocol and statistical analysis plan, may also be made available upon reasonable request.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 16 months is below that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartEst.
Sep 21, 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jul 2028
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 exclusion criterion added; 1 criterion edited, 25 removed
What changed in the criteria
  • EditedStream 1: Military members and Veterans receiving the DBR Intervention:
  • RemovedInclusion Criteria
  • RemovedExclusion Criteria
  • RemovedStream 2: Civilian and other TAPs receiving the DBR Intervention:
  • RemovedInclusion Criteria
  • Removed≥ 18 years old
  • RemovedTrauma-related disorder, moral injury, another post-traumatic mental health condition (e.g., Post traumatic stress injury (PTSI)), or a mental health condition arising as a consequence of a trauma or extreme stress.
  • RemovedIf on psychiatric medications: stable ≥ 4 weeks
  • RemovedFluent in English
  • RemovedAbility to provide informed consent and participate in therapy sessions
  • RemovedExclusion Criteria
  • RemovedActive psychosis or mania.
  • RemovedHigh-risk suicidal intent requiring acute intervention
  • RemovedSubstance use disorder requiring medical withdrawal, or likely interfering with therapy engagement
  • RemovedCognitive impairment limiting informed consent
  • RemovedCurrent participation in trauma-focused psychotherapy
  • RemovedCurrently involved in litigation
  • RemovedThe participant's condition is unlikely to benefit from short-term therapy. For our participant's well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions. It is likely that some potential participants will not be ready for trauma therapy.
  • RemovedAny condition that, in the clinical opinion of study psychiatrists or clinicians would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homelessness, ongoing psychosocial crisis, etc).
  • RemovedParticipants will be asked to refrain from starting any new treatment for PTSD until study participation is complete and pause other trauma-focused therapy.
  • RemovedStream 3: Clinicians Receiving the DBR Training and Clinical Consultation:
  • RemovedInclusion Criteria
  • RemovedMental Health Clinicians licensed to provide psychotherapy interventions in Canada
  • RemovedFluent in English
  • RemovedWilling to provide informed consent for the study procedures
  • RemovedConfidence and experience treating trauma and dissociation, including previous training in trauma-focused psychotherapies.
Exclusion criteria
  • AddedWe are currently actively recruiting participants for Stream 1 only, exclusively military veterans.
Oct 5, 2026
Interventions
Arm changed Stream 1: Military Members and Veterans - DBR Group→Stream 1: Military Veterans - DBR Group; Stream 1: Military Members and Veterans - Waitlist/Treatment as Usual→Stream 1: Military Veterans - Waitlist/Treatment as Usual. Arms removed: Stream 2: Trauma-Affected Civilians - DBR
Oct 5, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 5, 2026
    Eligibility 1 exclusion criterion added; 1 criterion edited, 25 removed
    What changed in the criteria
    • EditedStream 1: Military members and Veterans receiving the DBR Intervention:
    • RemovedInclusion Criteria
    • RemovedExclusion Criteria
    • RemovedStream 2: Civilian and other TAPs receiving the DBR Intervention:
    • RemovedInclusion Criteria
    • Removed≥ 18 years old
    • RemovedTrauma-related disorder, moral injury, another post-traumatic mental health condition (e.g., Post traumatic stress injury (PTSI)), or a mental health condition arising as a consequence of a trauma or extreme stress.
    • RemovedIf on psychiatric medications: stable ≥ 4 weeks
    • RemovedFluent in English
    • RemovedAbility to provide informed consent and participate in therapy sessions
    • RemovedExclusion Criteria
    • RemovedActive psychosis or mania.
    • RemovedHigh-risk suicidal intent requiring acute intervention
    • RemovedSubstance use disorder requiring medical withdrawal, or likely interfering with therapy engagement
    • RemovedCognitive impairment limiting informed consent
    • RemovedCurrent participation in trauma-focused psychotherapy
    • RemovedCurrently involved in litigation
    • RemovedThe participant's condition is unlikely to benefit from short-term therapy. For our participant's well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions. It is likely that some potential participants will not be ready for trauma therapy.
    • RemovedAny condition that, in the clinical opinion of study psychiatrists or clinicians would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homelessness, ongoing psychosocial crisis, etc).
    • RemovedParticipants will be asked to refrain from starting any new treatment for PTSD until study participation is complete and pause other trauma-focused therapy.
    • RemovedStream 3: Clinicians Receiving the DBR Training and Clinical Consultation:
    • RemovedInclusion Criteria
    • RemovedMental Health Clinicians licensed to provide psychotherapy interventions in Canada
    • RemovedFluent in English
    • RemovedWilling to provide informed consent for the study procedures
    • RemovedConfidence and experience treating trauma and dissociation, including previous training in trauma-focused psychotherapies.
    Exclusion criteria
    • AddedWe are currently actively recruiting participants for Stream 1 only, exclusively military veterans.
    Interventions Arm changed Stream 1: Military Members and Veterans - DBR Group→Stream 1: Military Veterans - DBR Group; Stream 1: Military Members and Veterans - Waitlist/Treatment as Usual→Stream 1: Military Veterans - Waitlist/Treatment as Usual. Arms removed: Stream 2: Trauma-Affected Civilians - DBR
    + 2 other changes: description and design details
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840417
Collaborators
Western University, University of Ottawa
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC
Contact
mindlab@ualberta.ca
780-342-5635
Lisa Burback (Psychiatrist and Associate Clinical Professor), BSc(Pharm), MD, FRCPC
Contact
burback@ualberta.ca

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion