Deep Brain Reorienting for Posttraumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Alberta
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Deep Brain Reorienting
BehavioralDeep 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)
BehavioralThis intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Stream 1: Military Veterans - DBR GroupExperimental treatment 1 intervention
Group B: Stream 1: Military Veterans - Waitlist/Treatment as UsualActive comparator 1 intervention
Trial outcomes
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-up2
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-up3
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 trainingSecondary 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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov