[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657767":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":49,"interventions":62,"overallOfficials":41,"centralContacts":72,"locations":81,"responsibleParty":100,"collaborators":102,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":41,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":41,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":84,"whyStopped":41,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"University of Alberta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":41},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"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\u002Fincapacitating) and summed to produce a total score ranging from 0 to 80. Higher scores indicate more severe PTSD symptoms.","From initial assessment to post-treatment at 8 weeks and the 3-month follow-up",{"measure":14,"description":15,"timeFrame":16},"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.","From baseline to post-treatment at 8 weeks and the 3-month follow-up",{"measure":18,"description":19,"timeFrame":20},"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.","Post DBR training",[22,26,29,32,35,38],{"measure":23,"description":24,"timeFrame":25},"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.","From baseline to post-treatment at 8 weeks, and the 3-month follow-up",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":16},"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.",{"measure":33,"description":34,"timeFrame":16},"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.",{"measure":36,"description":37,"timeFrame":16},"Change From Baseline in Physical Symptoms at 8 Weeks and 3-Month Follow-Up as Assessed by the PSS","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.",{"measure":39,"description":40,"timeFrame":16},"Change From Baseline in Emotion Regulation at 8 Weeks and 3-Month Follow-Up as Assessed by the DERS-16","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.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Stream 1 (military veterans) is a randomized, parallel-group feasibility trial. Participants will be assigned to DBR or a waitlist with treatment as usual. Researchers will compare outcomes after the 8-week treatment or waitlist period. After the 3-month follow-up, waitlist participants will be offered DBR and may cross over to the treatment.\n\nThe information provided below applies to Stream 1 only. We are currently actively recruiting participants for Stream 1 only, exclusively military veterans. Stream 1 is a two-arm randomized feasibility trial comparing DBR with a waitlist and treatment as usual.","TREATMENT",{"masking":48,"maskingDescription":41,"whoMasked":41},"NONE",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Stream 1: Military Veterans - DBR Group","EXPERIMENTAL","Military veterans who are randomized to receive eight weekly sessions of Deep Brain Reorienting (DBR).",[55],"Behavioral: Deep Brain Reorienting",{"label":57,"type":58,"description":59,"interventionNames":60},"Stream 1: Military Veterans - Waitlist\u002FTreatment as Usual","ACTIVE_COMPARATOR","Military veterans are 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.",[61],"Behavioral: Treatment as Usual (TAU)",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":41},"BEHAVIORAL","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.\n\nDBR will be administered by certified, experienced trauma clinicians, such as psychiatrists and psychotherapists. Each DBR session will include the following:\n\n* Identification of orienting tension\n* Attunement to shock activation\n* Integration of affective sequences\n* Resolution of trauma-encoded brainstem orientation patterns",[51],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":41},"Treatment as Usual (TAU)","This intervention means that participants will receive 8 weeks of treatment as usual without DBR or other trauma-focused therapy.",[57],[73,78],{"name":74,"role":75,"phone":76,"phoneExt":41,"email":77},"Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC","CONTACT","780-342-5635","mindlab@ualberta.ca",{"name":79,"role":75,"phone":41,"phoneExt":41,"email":80},"Lisa Burback (Psychiatrist and Associate Clinical Professor), BSc(Pharm), MD, FRCPC","burback@ualberta.ca",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Alberta Hospital Edmonton","RECRUITING","Edmonton","Alberta","T5Y 6A8","Canada","CA",{"type":91,"coordinates":92},"Point",[93,94],-113.46871,53.55014,{"lat":94,"lon":93},[97,99],{"name":74,"role":75,"phone":76,"phoneExt":41,"email":98},"ow@ualberta.ca",{"name":79,"role":75,"phone":41,"phoneExt":41,"email":80},{"type":101,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[103,105],{"name":104,"class":6},"Western University",{"name":106,"class":6},"University of Ottawa","100657767","deep-brain-reorienting-for-posttraumatic-stress-disorder-100657767",false,"NCT07840417","Deep Brain Reorienting for Posttraumatic Stress Disorder","Stream 1: Military Veterans receiving the DBR Intervention:\n\nInclusion Criteria\n\n* 18 to 65 years old\n* Current or former military member \u002F Veteran (for Stream 1 only)\n* DSM-5 PTSD diagnosis determined via the CAPS-5\n* If on psychiatric medications: stable ≥ 4 weeks\n* Fluent in English\n* Ability to provide informed consent and participate in therapy sessions\n* Able to benefit from short-term therapy, as determined by study assessment\n\nExclusion Criteria\n\n* High-risk clinical state (e.g., suicidal or homicidal intent; substance withdrawal) requiring acute intervention.\n* History of moderate to severe head or brain injury leading to impaired functioning (e.g., a Glasgow Coma Scale Score \\\u003C 15 at the time of incident assessed retrospectively by participant; sustained loss of consciousness leading to impaired functioning)\n* Cognitive impairment limiting informed consent\n* Significant untreated medical illness\n* History of neurological disorder, pervasive developmental disorder, bipolar or psychotic disorder\n* Alcohol\u002Fsubstance use problems within the last 3 months requiring medical withdrawal or likely to interfere with therapy.\n* 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\u002Ftriggers brought up in treatment within the 8 sessions).\n* 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).\n\nOther considerations:\n\nParticipants 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.\n\nIf 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.\n\nParticipants 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.\n\nWe are currently actively recruiting participants for Stream 1 only, exclusively military veterans.","ALL","18 Years","65 Years",{"count":117,"type":118},50,"ESTIMATED","INTERVENTIONAL",[121],"NA","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:\n\n* Does DBR lower PTSD symptoms compared with treatment as usual?\n* Do PTSD symptoms stay lower three months after treatment?\n\nResearchers will compare waitlist to see if DBR works to treat PTSD.\n\nParticipants will:\n\n* Receive eight DBR sessions, each lasting about 50 minutes\n* Answer questions before and after treatment and 3 months later\n* Complete short questionnaires before and after each session\n* Complete an interview about their experience of DBR",[124,125],"Posttraumatic Stress Disorder (PTSD)","Posttraumatic Stress Symptom",[127,128,65,129,130],"posttraumatic disorder","PTSD","trauma-focused therapy","RCT","2026-09-29",{"date":133,"type":134},"2026-10-05","ACTUAL",{"date":136,"type":118},"2026-09-21",{"date":138,"type":118},"2028-07",{"name":5,"class":6},1]