Clinical trial for Posttraumatic Stress Disorder (PTSD)
Official title Deep Brain Reorienting for Posttraumatic Stress Disorder
ClinicalTrials.gov ID: NCT07840417
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if Deep Brain Reorienting (DBR) works to treat posttraumatic stress disorder (PTSD) symptoms in military members and veterans. The main questions it aims to answer are: Does DBR lower PTSD symptoms compared with treatment as usual?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Stream 1: Military members and Veterans receiving the DBR Intervention:
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Stream 1: Military members and Veterans receiving the DBR Intervention:
- 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
- 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...
- 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...
- 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...
- ≥ 18 years old
- Trauma-related disorder, moral injury, another post-traumatic mental health condition (e.g., Post traumatic stress injury (PTSI)), or a mental health condition arising as a consequence of a trauma or extreme stress.
- If on psychiatric medications: stable ≥ 4 weeks
- Fluent in English
- Ability to provide informed consent and participate in therapy sessions Exclusion Criteria
- Active psychosis or mania.
- High-risk suicidal intent requiring acute intervention
- Substance use disorder requiring medical withdrawal, or likely interfering with therapy engagement
- Cognitive impairment limiting informed consent
- Current participation in trauma-focused psychotherapy
- Currently involved in litigation
- The participant's condition is unlikely to benefit from 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...
- 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., homelessness, ongoing...
- Participants will be asked to refrain from starting any new treatment for PTSD until study participation is complete and pause other trauma-focused therapy. Stream 3: Clinicians Receiving the DBR Training and Clinical...
- Mental Health Clinicians licensed to provide psychotherapy interventions in Canada
- Fluent in English
- Willing to provide informed consent for the study procedures
- Confidence and experience treating trauma and dissociation, including previous training in trauma-focused psychotherapies.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.