Alberta Hospital Edmonton
Edmonton, Alberta, T5Y 6A8, Canada
Location status: Recruiting
NCT Number: NCT07840417
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
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, T5Y 6A8, Canada
Location status: Recruiting
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
Exclusion criteria
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
Exclusion criteria
Stream 3: Clinicians Receiving the DBR Training and Clinical Consultation:
Inclusion criteria
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:
This intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.
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.
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.
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.
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.
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.
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.
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.
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.
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?
Request InfoUniversity of Alberta
Other
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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