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NCT04317820

Deep Brain Reorienting in Post-traumatic Stress Disorder

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 14 versions: 11 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jul 2027 to Jul 2028 Show 5 more changesShow less
    • Enrollment reopened
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 25 words
    • Site details revised
    • Publications: details revised at 5 of 5 entries
  2. Notable Primary and study completion dates: Jun 2026 to Jul 2027
    • Enrollment target: 214 to 234
    v13
  3. Notable Primary and study completion dates: Sep 2025 to Jun 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  4. Notable Enrollment target: 124 to 214v11
  5. Notable Primary and study completion dates: Sep 2024 to Sep 2025v9
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary and study completion dates: Sep 2023 to Sep 2024v8
  2. Notable Primary and study completion dates: Sep 2022 to Sep 2023v7
  3. Minor Enrollment target: 84 to 124
    • Eligibility criteria shortened, about 7 words
    v6
  4. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Apr 2022 to Sep 2022
    • Start date changed from estimate of Jul 2020 to Sep 29, 2020
    • Study description expanded, about 9 words
  5. Notable Enrollment target: 42 to 84
    • Start date: Apr 2020 to Jul 2020
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 15 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Arms and interventions

DBR ConditionExperimental

Involves 8 weekly sessions of DBR treatment.

Wait-list ConditionNo intervention

No intervention for approximately 8 weeks.

Behavioral: Deep Brain Reorienting (DBR)

Sites

1 site in 1 country

  • London Health Sciences Centre - University HospitalLondon, Ontario, Canada