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NCT Number: NCT07840417

Deep Brain Reorienting for Posttraumatic Stress Disorder

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Hospital Edmonton

Edmonton, Alberta, T5Y 6A8, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep Brain Reorienting

Behavioral

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)

Behavioral

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

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

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

    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.

  2. 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

    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.

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

    Time frame: Post DBR training

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • University of Ottawa
  • Western University

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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