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New treatment option for Post-Traumatic Stress Disorder in Adolescence
Official title The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents
ClinicalTrials.gov ID: NCT06854328
What this study is testing
- What it's testing
- Prism is a software as a medical device (SaMD) to be prescribed by clinicians as an adjunct to the standard of care treatment of patients with PTSD. The Prism software device runs on a laptop using an EEG signal input (g).Nautilos PRO (K171669).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Ages 12 to 21 years.
- Any gender.
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- ≥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...
You likely can't join if
- Have completed one or more full courses of trauma-focused therapy in the past (i.e., Eye Movement Desensitization and Reprocessing [EMDR], Prolong...
- Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
- 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...
- Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
- 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)...
- Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
See the full eligibility criteria
- Ages 12 to 21 years.
- Any gender.
- Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- ≥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 years 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.
- Have completed one 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...
- Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.
- 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...
- Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.
- 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.
- Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.
- Any change in- or initiation of- psychotropic medications within the past 4 weeks. At the time of recruitment, people must have no intention of changing their medication or psychotherapy during the study duration.
- Any suicidal behavior within the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior), prior to screening and during the screening period.
- 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...
- 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...
- Any unstable medical condition, as per the clinical judgement of the investigator.
- Enrollment in another treatment clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.
- Female people who are pregnant, nursing, or who plan to become pregnant while in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Ramat Gan, Israel
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, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Ramat Gan, Israel. 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.