Deep Brain Reorienting in Post-traumatic Stress Disorder

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04317820
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
124
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Deep Brain Reorienting (DBR)
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to either the DBR treatment or wait-list conditions.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.
Primary Purpose:
Treatment
Official Title:
The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)
Actual Study Start Date :
Sep 29, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment [8 weeks]

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

  2. change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre - University Hospital London Ontario Canada N6A 5A5

Sponsors and Collaborators

  • Lawson Health Research Institute
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Ruth A Lanius, MD, PhD, Lawson Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ruth Lanius, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT04317820
Other Study ID Numbers:
  • 8997
  • 114501
First Posted:
Mar 23, 2020
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ruth Lanius, Principal Investigator, Lawson Health Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2022