Recruiting

DBR

Sponsor:

University of Alberta

Code:

NCT07840417

Conditions

Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Symptom

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Deep Brain Reorienting

Treatment as Usual (TAU)

Study Details

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

Conditions

Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Symptom

Study ID

NCT07840417

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Stream 1: Military members and Veterans receiving the DBR Intervention:

Inclusion Criteria

  • 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

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 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:

Inclusion Criteria

  • ≥ 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.
  • If on psychiatric medications: stable ≥ 4 weeks
  • Fluent in English
  • Ability to provide informed consent and participate in therapy sessions

Exclusion Criteria

  • Active psychosis or mania.
  • High-risk suicidal intent requiring acute intervention
  • Substance use disorder requiring medical withdrawal, or likely interfering with therapy engagement
  • Cognitive impairment limiting informed consent
  • Current participation in trauma-focused psychotherapy
  • Currently involved in litigation
  • The 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.
  • 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., homelessness, ongoing psychosocial crisis, etc).
  • Participants will be asked to refrain from starting any new treatment for PTSD until study participation is complete and pause other trauma-focused therapy.

Stream 3: Clinicians Receiving the DBR Training and Clinical Consultation:

Inclusion Criteria

  • Mental Health Clinicians licensed to provide psychotherapy interventions in Canada
  • Fluent in English
  • Willing to provide informed consent for the study procedures
  • Confidence and experience treating trauma and dissociation, including previous training in trauma-focused psychotherapies.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stream 1: Military Members and Veterans - DBR Group

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

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

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.

experimental: Stream 2: Trauma-Affected Civilians - DBR

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.

Interventions

Deep 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

Treatment as Usual (TAU)

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

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 ]
  • Change From Baseline in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the PCL-5 [ Time Frame: 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 [ Time Frame: Post DBR training ]

Central Contacts and Locations

Central contacts

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

780-342-5635mindlab@ualberta.ca

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

burback@ualberta.ca

Locations

Alberta Hospital Edmonton

Recruiting

Edmonton, Alberta, Canada, T5Y 6A8

Contacts

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

780-342-5635ow@ualberta.ca

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

burback@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.