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New treatment option for Post Traumatic Stress Disorder
Official title Multi-session fMRI-Neurofeedback in PTSD
ClinicalTrials.gov ID: NCT05456958
What this study is testing
- What it's testing
- Post-traumatic stress disorder (PTSD) is a debilitating and highly prevalent psychiatric disorder that develops in the aftermath of trauma exposure (APA, 2013). PTSD has been strongly associated with altered activation patterns within several large-scale brain networks and, as such, it has been suggested that normalizing pathological brain activation may be an effective treatment approach.
- Which group you join is decided by chance.
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
- 18-65 years old
- Fluent English speaker
- Comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.)
- Meet criteria for a primary diagnosis of PTSD via the DSM-5 on the Clinician Administered PTSD Scale (CAPS-5). Note: given high rates of PTSD...
- Able to provide written informed consent.
You likely can't join if
- Medical
- Pregnant women or women who are breastfeeding
- Serious illness (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) that is not stabilized based on...
- Contraindications for research MRI, including metallic implants
- Neurological disease, past head injury with loss of consciousness, stroke, seizures
- Major untreated medical illness (e.g., cancer, thyroid disorder)
See the full eligibility criteria
- 18-65 years old
- Fluent English speaker
- Comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.)
- Meet criteria for a primary diagnosis of PTSD via the DSM-5 on the Clinician Administered PTSD Scale (CAPS-5). Note: given high rates of PTSD co-morbidity with major depressive disorder and anxiety disorders, these...
- Able to provide written informed consent.
- Medical
- Pregnant women or women who are breastfeeding
- Serious illness (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) that is not stabilized based on the judgment of primary investigator
- Contraindications for research MRI, including metallic implants
- Neurological disease, past head injury with loss of consciousness, stroke, seizures
- Major untreated medical illness (e.g., cancer, thyroid disorder)
- Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol. Psychological/Psychiatric
- Active substance use or abuse as defined by the MINI or judged to be a problem by the PI
- Current or past pain disorders, bipolar disorders or psychosis, schizophrenia, and any other psychotic disorder will be excluded
- Participants will also be excluded for active suicidality, history of pervasive developmental disorders, or any other major medical illnesses
- Meeting criteria for substance use disorder in the past three months on the MINI
- Chronic opioid analgesic use within the last three months
- Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol
- Current engagement in a primary trauma-focused psychotherapy treatment. Other
- History of claustrophobia
- Previous engagement in biofeedback, neurofeedback, or any form of brain stimulation therapy.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, 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 London, Ontario, 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.