Deep Brain Reorienting for PTSD in Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates the safety and effectiveness of Deep Brain Reorienting (DBR) for PTSD symptoms in veterans. Participants receive eight DBR sessions, each about 50 minutes, with assessments before, after, and at a 3-month follow-up. The study compares DBR to treatment as usual and includes a waitlist arm to determine if DBR produces symptom improvement. Eligible veterans undergo CAPS-5 confirmation of PTSD, must be fluent in English, and have stable medical and psychiatric status to participate. Overall, the study uses a randomized or quasi-randomized design to see if DBR can reduce PTSD symptoms and sustain gains over three months.

Why it matters

Who can join: the full rules

Stream 1: Military Veterans receiving the DBR Intervention:

Inclusion Criteria

* 18 to 65 years old
* Current or former military member / Veteran (for Stream 1 only)
* DSM-5 PTSD diagnosis determined via the CAPS-5
* If on psychiatric medications: stable ≥ 4 weeks
* Fluent in English
* Ability to provide informed consent and participate in therapy sessions
* Able to benefit from short-term therapy, as determined by study assessment

Exclusion Criteria

* High-risk clinical state (e.g., suicidal or homicidal intent; substance withdrawal) requiring acute intervention.
* History of moderate to severe head or brain injury leading to impaired functioning (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident assessed retrospectively by participant; sustained loss of consciousness leading to impaired functioning)
* Cognitive impairment limiting informed consent
* Significant untreated medical illness
* History of neurological disorder, pervasive developmental disorder, bipolar or psychotic disorder
* Alcohol/substance use problems within the last 3 months requiring medical withdrawal or likely to interfere with therapy.
* Degree of mental distress that is unlikely to benefit from a short-term therapy (for our participant's 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).
* Any condition that, in the clinical opinion of study psychiatrists or clinicians, would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homeless, ongoing psychosocial crisis, etc).

Other considerations:

Participants will be asked not to start any new PTSD treatments (medications or psychotherapy) 4 weeks prior to study enrollment and until study participation is complete.

If already taking psychiatric medications, doses must be stable for at least 4 weeks prior to enrolling in the study, and remain stable until study completion.

Participants in DBR stream must be able and willing to pause other trauma-focused psychotherapies (e.g., CPT, EMDR, exposure therapy) while receiving DBR in the study. Non-trauma focused therapies (e.g. CBT) or supportive talk with a therapist may continue.

We are currently actively recruiting participants for Stream 1 only, exclusively military veterans.

Where it's running

• Alberta Hospital Edmonton
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Olga Winkler (Psychiatrist and Associate Clinical Professor), MD, FRCPC
• Email: mindlab@ualberta.ca
• Phone: 780-342-5635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.