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Deep Brain Reorienting i Posttraumatisk Stress Disorder

Effekterne af Deep Brain Reorienting (DBR) på posttraumatisk stresslidelse (PTSD)

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.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

234

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Rekruttering
        • London Health Sciences Centre - University Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Ingen indgriben: Wait-list Condition

No intervention for approximately 8 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment
Tidsramme: 8 weeks

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

8 weeks
change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment
Tidsramme: 3 months

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

3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ruth A Lanius, MD, PhD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. september 2020

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

18. marts 2020

Først indsendt, der opfyldte QC-kriterier

20. marts 2020

Først opslået (Faktiske)

23. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 8997
  • 114501 (Anden identifikator: Western University's Human Research Ethics)

Plan for individuelle deltagerdata (IPD)

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