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Deep Brain Reorienting in Post-traumatic Stress Disorder

Primary Purpose

PTSD, Post-traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Deep Brain Reorienting (DBR)

About this trial

This is an interventional treatment trial for PTSD focused on measuring Deep Brain Reorienting, DBR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

London Health Sciences Centre - University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DBR Condition

Wait-list Condition

Arm Description

Involves 8 weekly sessions of DBR treatment.

No intervention for approximately 8 weeks.

Outcomes

Primary Outcome Measures

change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment

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

min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT04317820

First Posted

March 18, 2020

Last Updated

October 20, 2022

Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT04317820

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 29, 2020 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Post-traumatic Stress Disorder

Keywords

Deep Brain Reorienting, DBR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized to either the DBR treatment or wait-list conditions.

Masking

Outcomes Assessor

Masking Description

Only the outcome assessors will be blinded to which condition the participant was assigned.

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DBR Condition

Arm Type

Experimental

Arm Description

Involves 8 weekly sessions of DBR treatment.

Arm Title

Wait-list Condition

Arm Type

No Intervention

Arm Description

No intervention for approximately 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Deep Brain Reorienting (DBR)

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment

Description

min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms

Time Frame

8 weeks

Title

change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment

Description

min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suzy - Study Coordinator

Phone

519-685-8500

Ext

35186

Suzy.Southwell@lhsc.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth A Lanius, MD, PhD

Organizational Affiliation

Lawson Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Centre - University Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suzy -Study Coordinator

Phone

519-685-8500

Ext

35186

suzy.southwell@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18059264

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.

Results Reference

background

PubMed Identifier

28813307

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.

Results Reference

background

PubMed Identifier

32440590

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.

Results Reference

background

PubMed Identifier

22514521

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.

Results Reference

background

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Deep Brain Reorienting in Post-traumatic Stress Disorder

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