Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT05456958
Eligibility Criteria:
Inclusion 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 participants will not be excluded from the study, allowing for a naturalistic sample
* Able to provide written informed consent.
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05456958
Study Brief:
Protocol Section:
NCT05456958