The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents

Eligibility Criteria

• 1. Ages 12 to 21 years.
• 2. Any gender.
• 3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
• 4. ≥1 year since index trauma.
• 5. 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.
• 6. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.
• 7. English speaking, writing and reading.
• 8. Normal or corrected-to-normal vision and hearing.
• 1. Have completed two or more full courses of trauma-focused therapy in the past (i.e., Eye Movement Desensitization and Reprocessing \[EMDR\], Prolong Exposure Therapy etc.), eligibility will be deemed upon the clinical judgement of the investigator.
• 2. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
• 3. Any mood or anxiety disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), that has been the primary focus of mental health treatment within the 6 months prior to screening, based on the clinical judgment of the site investigator.
• 4. Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
• 5. Diagnosis of moderate or severe substance use disorder within the last 3 months of the screening visit (as defined in DSM-5-substance use disorder) or at the screening visit.
• 6. Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
• 7. 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.
• 8. Any history of suicidal behavior (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
• 9. 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.
• 10. 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).
• 11. Any unstable medical condition, as per the clinical judgement of the investigator.
• 12. Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
• 13. Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.