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:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT04496557
Eligibility Criteria:
Inclusion Criteria:
* Adults ages 18-65 years
* Able to provide signed informed consent
* Any gender
* Diagnosis of PTSD as established by DSM-V
* 1 to 15 years since index trauma
* Taking a stable dose of SSRI antidepressants for at least 3 months OR un-medicated for at least 2 months
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing
* No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment
Exclusion Criteria:
* Concurrent substance abuse
* Use of any prescribed benzodiazepine
* Lifetime bipolar disorder, psychotic disorder, autism, mental retardation. Comorbid mood and anxiety disorders will be permitted if they are not the primary focus of clinical attention
* Active suicidality within past year, or history of suicide attempt in past 2 years
* Any history of severe past drug dependence (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
* Any unstable medical or neurological condition
* Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \[TBI\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
* Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs)
* Any change in accepted psychotropic medication within the past 2 months
* Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \[CPT\], Prolonged Exposure \[PE\], Eye Movement -Desensitization and Reprocessing \[EMDR\]); continuation of established maintenance supportive therapy will be permitted
* Significant hearing loss or severe sensory impairment
* Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04496557
Study Brief:
Protocol Section:
NCT04496557