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Posttraumatic Stress Disorder (PTSD)NCT07840417

Deep Brain Reorienting for Posttraumatic Stress Disorder

A study testing Deep Brain Reorienting and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Posttraumatic Stress Symptom, run by University of Alberta at 1 site in Canada.

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 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Deep Brain Reorienting and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
21 Sep 2026to Jul 2028
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 informed consent
  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

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

Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC contact

780-342-5635

mindlab@ualberta.ca

Lisa Burback (Psychiatrist and Associate Clinical Professor), BSc(Pharm), MD, FRCPC contact

burback@ualberta.ca

Canada1 site, 1 recruiting

  • Alberta Hospital Edmonton

    Edmonton, Alberta, T5Y 6A8

    Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC, 780-342-5635, ow@ualberta.ca

    Lisa Burback (Psychiatrist and Associate Clinical Professor), BSc(Pharm), MD, FRCPC, burback@ualberta.ca

    Recruiting

Other trials in Canada

About this study

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
Being tested
Deep Brain Reorienting, Treatment as Usual (TAU)
Keywords
posttraumatic disorder, PTSD, Deep Brain Reorienting, trauma-focused therapy, RCT
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.

  • Deep Brain ReorientingBehavioural

    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

  • Treatment as Usual (TAU)Behavioural

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

Study groups in NCT07840417
Study groupRoleWhat they receive
Stream 1: Military Veterans - DBR GroupExperimentalMilitary veterans who are randomized to receive eight weekly sessions of Deep Brain Reorienting (DBR).
Receives: Behavioral: Deep Brain Reorienting
Stream 1: Military Veterans - Waitlist/Treatment as UsualActive comparatorMilitary 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.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

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

  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.

    Measured: 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.

    Measured: 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.

    Measured: Post DBR training

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

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

  1. First posted25 Sep 2026
  2. Study start21 Sep 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2028 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stream 1 (military veterans) is a randomized, parallel-group feasibility trial. Participants will be assigned to DBR or a waitlist with treatment as usual. Researchers will compare outcomes after the 8-week treatment or waitlist period. After the 3-month follow-up, waitlist participants will be offered DBR and may cross over to the treatment. The information provided below applies to Stream 1 only. We are currently actively recruiting participants for Stream 1 only, exclusively military veterans. Stream 1 is a two-arm randomized feasibility trial comparing DBR with a waitlist and treatment as usual.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840417
Sponsor's protocol ID
Pro00160040
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Reorienting and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Posttraumatic Stress Symptom, run by University of Alberta at 1 site in Canada.

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 7 inclusion and 13 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 5 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 Canada. 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.

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 Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC (780-342-5635, mindlab@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Initial Assessment in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the CAPS-5 (time frame: From initial assessment to post-treatment at 8 weeks and the 3-month follow-up). The study lists 3 primary outcomes in all. 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 NCT07840417, which also lists 9 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 5 Oct 2026.

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