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- Essai clinique NCT04317820
Réorientation cérébrale profonde dans le trouble de stress post-traumatique
Les effets de la réorientation profonde du cerveau (DBR) sur le trouble de stress post-traumatique (SSPT)
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.
While enrollment for the first phase of the study has ended, a second phase has begun, which focuses on DBR treatment in military veterans.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
While enrollment for the first phase of the study has ended, a second phase has begun, which focuses on DBR treatment in 20 military veterans.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Suzy - Study Coordinator
- Numéro de téléphone: 35186 519-685-8500
- E-mail: Suzy.Southwell@lhsc.on.ca
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6A 5A5
- Recrutement
- London Health Sciences Centre - University Hospital
-
Contact:
- Suzy -Study Coordinator
- Numéro de téléphone: 35186 519-685-8500
- E-mail: suzy.southwell@lhsc.on.ca
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- military veteran
- 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:
- not a military veteran
- 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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: DBR Condition
Involves 8 weekly sessions of DBR treatment. |
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. |
|
Aucune intervention: Wait-list Condition
No intervention for approximately 8 weeks. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment
Délai: 8 weeks
|
min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms |
8 weeks
|
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change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment
Délai: 3 months
|
min. CAPS score=0, max=80, with higher scores representing greater PTSD symptoms |
3 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ruth A Lanius, MD, PhD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- Kearney BE, Corrigan FM, Frewen PA, Nevill S, Harricharan S, Andrews K, Jetly R, McKinnon MC, Lanius RA. A randomized controlled trial of Deep Brain Reorienting: a neuroscientifically guided treatment for post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2240691. doi: 10.1080/20008066.2023.2240691.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8997
- 114501 (Autre identifiant: Western University's Human Research Ethics)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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