NCT07840417

Brief 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 members and 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jul 2028

First Submitted

Initial submission to the registry

September 18, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

posttraumatic disorderPTSDDeep Brain Reorientingtrauma-focused therapyRCT

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

    Post DBR training

Secondary Outcomes (6)

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

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

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

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

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

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

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

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

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

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

  • +1 more secondary outcomes

Study Arms (3)

Stream 1: Military Members and Veterans - DBR Group

EXPERIMENTAL

Canadian Armed Forces members and Veterans randomized to receive eight weekly sessions of Deep Brain Reorienting (DBR).

Behavioral: Deep Brain Reorienting

Stream 1: Military Members and Veterans - Waitlist/Treatment as Usual

ACTIVE COMPARATOR

Canadian Armed Forces members and Veterans 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)

Stream 2: Trauma-Affected Civilians - DBR

EXPERIMENTAL

Trauma-affected civilian participants will receive eight sessions of DBR in an open-label study. Treatment may be extended to a maximum of 20 sessions when clinically indicated.

Behavioral: Deep Brain Reorienting

Interventions

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

Stream 1: Military Members and Veterans - DBR GroupStream 2: Trauma-Affected Civilians - DBR

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

Stream 1: Military Members and Veterans - Waitlist/Treatment as Usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.
  • Stream 2: Civilian and other TAPs receiving the DBR Intervention:
  • ≥ 18 years old
  • Trauma-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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Hospital Edmonton

Edmonton, Alberta, T5Y 6A8, Canada

RECRUITING

Related Publications (9)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 40098781BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31794877BACKGROUND
  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006 Jan;3(2):77-101.

    BACKGROUND
  • 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.

    PMID: 37581275BACKGROUND
  • 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

    BACKGROUND
  • Panksepp J. Affective Neuroscience: the foundations of human and animal emotions. New York: Oxford University Press; 1998.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

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

CONTACT

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stream 1 (military members and 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. Stream 2 (civilians) is a non-randomized, open-label study. Participants will receive eight DBR sessions, with up to 20 sessions available when clinically appropriate. There is no control group. Stream 3 (clinicians receive Deep Brain Reorienting training): Online-delivered therapist training will include three two-day trainings (e.g., Levels 1 to 3), each incorporating didactic and experiential components. The information provided below applies to Stream 1 only. Stream 1 is a two-arm randomized feasibility trial comparing DBR with a waitlist and treatment as usual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Locations