Adolescents: A Prospective Single Arm Open Label Trial to Confirm Safety and Effectiveness of Prism as an Adjunct to Standard of Care in Adolescents with Post-Traumatic Stress Disorder (PTSD)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Post-traumatic Stress Disorder (ptsd)
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Age: Between 12 Year(s) - 21 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Ages 12 to 21 years.
- Any gender.
- Diagnosis of PTSD.
- ≥1 year since index trauma.
- For candidate participants under 18 years old: Willingness and ability to provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation.
- For candidate participants 18-year-old and above: Willingness and ability to provide informed consent for their study participation.
- English speaking, writing and reading.
- Normal or corrected-to-normal vision and hearing.
You may not be eligible for this study if the following are true:
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- Have completed one or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy etc.).
- Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
- Diagnosis of autism spectrum requiring substantial support.
- Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit.
- Current symptom level of moderate or severe ADHD or at screening visit.
- Any change in- or initiation of- psychotropic medications within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration.
- Any history of suicidal behavior (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- 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]). However, continuation of established maintenance supportive therapy will be permitted.
- 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).
- Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
- Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.