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Deep Brain Reorienting in Post-traumatic Stress Disorder

L

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Enrolling

Conditions

Post-traumatic Stress Disorder
PTSD

Treatments

Behavioral: Deep Brain Reorienting (DBR)

Study type

Interventional

Funder types

Other

Identifiers

NCT04317820
114501 (Other Identifier)
8997

Details and patient eligibility

About

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.

Full 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).

Enrollment

214 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

214 participants in 2 patient groups

DBR Condition
Experimental group
Description:
Involves 8 weekly sessions of DBR treatment.
Treatment:
Behavioral: Deep Brain Reorienting (DBR)
Wait-list Condition
No Intervention group
Description:
No intervention for approximately 8 weeks.

Trial contacts and locations

1

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Central trial contact

Suzy - Study Coordinator

Data sourced from clinicaltrials.gov

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