Comparing Deep Brain Reorienting with Treatment as Usual for posttraumatic stress disorder (PTSD)
Official title: Deep Brain Reorienting for Posttraumatic Stress Disorder
- 2 groups
- One site, in Edmonton
- Recruiting
Interventions
- Behavioural therapy
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
- Behavioural therapy
Treatment as Usual (TAU)
This intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Alberta Hospital Edmonton
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and participate in therapy sessions
- +Able to benefit from short-term therapy, as determined by study assessment
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
- +We are currently actively recruitingRecruitingThe study is currently looking for participants.Read more → participants for Stream 1 only, exclusively military veterans.
Exclusion
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
- −We are currently actively recruitingRecruitingThe study is currently looking for participants.Read more → participants for Stream 1 only, exclusively military veterans.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Deep Brain Reorienting.
Registry label: A: Stream 1: Military Veterans - DBR Group
Group B, the comparison group, receives Treatment as Usual (TAU).
Registry label: B: Stream 1: Military Veterans - Waitlist/Treatment as Usual
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: From initial assessment to post-treatment at 8 weeks and the 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change From Initial Assessment in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-UpFollow-upContinued check-ins after the treatment part is finished.Read more → as Assessed by the CAPS-5 — measured over From initial assessment to post-treatment at 8 weeks and the 3-month follow-up.
Change From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the PCL-5 — measured over 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 — measured over Post DBR training.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07840417 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Deep Brain ReorientingBehavioural
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
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Treatment as Usual (TAU)Behavioural
This intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From initial assessment to post-treatment at 8 weeks and the 3-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2028-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.