Clinical trial NCT04317820: Deep Brain Reorienting in Post-traumatic Stress Disorder
Official title: The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Post-traumatic Stress Disorder
Keywords: Deep Brain Reorienting
DBR
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-03-23
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the DBR treatment or wait-list conditions.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). Participants will be randomized to either the DBR treatment, or wait-list condition.

Detailed description: This study will evaluate the efficacy of Deep Brain Reorienting (DBR) in reducing PTSD symptoms. DBR was designed by Dr. Frank Corrigan, a Scottish psychiatrist interested in the brain mechanisms underlying effective trauma psychotherapy. For this study, participants will be randomized to either the DBR treatment or wait-list study conditions. Trauma processing through DBR involves bringing up a traumatic memory and encourages the client to focus on tensions arising in the muscles of the shoulders, neck, head and face (i.e., those involved in orienting toward a threatening person/event). It is believed that this approach will allow the participant to process the traumatic memory in an emotionally manageable way, changing how it is represented/accessed in the brain's innate defensive system. Online Stream - Assessments will include clinical interviews (pre/post treatment, and follow-up) using Webex video conferencing, and fMRI (functional magnetic resonance imaging) scans (pre/post treatment). In-Person Stream - Assessment will include clinical interviews (pre/post treatment and follow-up), and fMRI scans (pre/post treatment).

Eligibility criteria: Inclusion Criteria:

* English speaking
* age: 18-65
* meets diagnostic criteria for PTSD (as determined by study assessment)
* may benefit from short-term trauma therapy (as determined by study assessment)

Exclusion Criteria:

* Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)
* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident assessed retrospectively by participant)
* significant untreated medical illness
* history of neurological disorder
* history of any pervasive developmental disorder
* history of bipolar disorder
* history of psychotic disorder
* alcohol/substance abuse or dependence within the last 3 months
* extensive narcotic use
* current participation in counselling more extensive than supportive therapy (e.g., exposure therapy, Cognitive-Behavioural Therapy would be an exclusion)
* a degree of mental distress that is unlikely to benefit from a short-term therapy (for our participants' 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).

Primary outcomes:
measure: change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment
timeFrame: 8 weeks
measure: change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ruth A Lanius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corneil BD, Munoz DP, Chapman BB, Admans T, Cushing SL. Neuromuscular consequences of reflexive covert orienting. Nat Neurosci. 2008 Jan;11(1):13-5. doi: 10.1038/nn2023. Epub 2007 Dec 2.
citation: Lanius RA, Rabellino D, Boyd JE, Harricharan S, Frewen PA, McKinnon MC. The innate alarm system in PTSD: conscious and subconscious processing of threat. Curr Opin Psychol. 2017 Apr;14:109-115. doi: 10.1016/j.copsyc.2016.11.006. Epub 2016 Nov 26.
citation: Terpou BA, Densmore M, Thome J, Frewen P, McKinnon MC, Lanius RA. The Innate Alarm System and Subliminal Threat Presentation in Posttraumatic Stress Disorder: Neuroimaging of the Midbrain and Cerebellum. Chronic Stress (Thousand Oaks). 2019 Feb 5;3:2470547018821496. doi: 10.1177/2470547018821496. eCollection 2019 Jan-Dec.
citation: Comoli E, Das Neves Favaro P, Vautrelle N, Leriche M, Overton PG, Redgrave P. Segregated anatomical input to sub-regions of the rodent superior colliculus associated with approach and defense. Front Neuroanat. 2012 Apr 3;6:9. doi: 10.3389/fnana.2012.00009. eCollection 2012.