Deep Brain Reorienting in Post-traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT04317820|
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : February 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|PTSD Post-traumatic Stress Disorder||Behavioral: Deep Brain Reorienting (DBR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to either the DBR treatment or wait-list conditions.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Only the outcome assessors will be blinded to which condition the participant was assigned.|
|Official Title:||The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)|
|Actual Study Start Date :||September 29, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: DBR Condition
Involves 8 weekly sessions of DBR treatment.
Behavioral: Deep Brain Reorienting (DBR)
Trauma processing through DBR involves bringing up a traumatic memory and encouraging 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). The rationale is as follows: Physiologically, orienting to a stimulus, whether external or in the mind's eye, comes before any affective response to it. Here, it is hypothesized that there is activity in certain midbrain structures , i.e.,Superior Colliculi (SC) and Periaqueductal Gray (PAG). The deep layers of the SC bring on a brief (orienting) tension in the neck as well as preparing for eye movements, which is later followed by the processing of raw affect in the PAG. In session, if we can attend to this tension - even if we have to backtrack from the emotion that follows - we can establish an anchor in the body that precedes the affect and is hypothesized to protect against emotional overwhelm.
No Intervention: Wait-list Condition
No intervention for approximately 8 weeks.
- change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment [ Time Frame: 8 weeks ]min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms
- change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment [ Time Frame: 3 months ]min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317820
|Contact: Suzy - Study Coordinator||519-685-8500 ext 35186||Suzy.Southwell@lhsc.on.ca|
|London Health Sciences Centre - University Hospital||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Suzy -Study Coordinator 519-685-8500 ext 35186 firstname.lastname@example.org|
|Principal Investigator:||Ruth A Lanius, MD, PhD||Lawson Health Research Institute|