[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-traumatic-stress-disorder-in-adolescence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-traumatic-stress-disorder-in-adolescence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100581747","the-prism-conformity-trial-for-post-traumatic-stress-disorder-in-adolescents-100581747",false,"NCT06854328","The Prism Conformity Trial for Post-Traumatic Stress Disorder in 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)","Inclusion Criteria:\n\n1. Ages 12 to 21 years.\n2. Any gender.\n3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).\n4. ≥1 year since index trauma.\n5. 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.\n6. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.\n7. English speaking, writing and reading.\n8. Normal or corrected-to-normal vision and hearing.\n\nExclusion Criteria:\n\n1. 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 judgement of the investigator.\n2. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.\n3. 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.\n4. Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.\n5. 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.\n6. Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.\n7. 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.\n8. 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.\n9. 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.\n10. 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).\n11. Any unstable medical condition, as per the clinical judgement of the investigator.\n12. Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.\n13. Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.","ALL","12 Years","21 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).\n\nThe primary objective of the study is to extend the use of the FDA cleared Prism for PTSD (K222101) to an adolescent population and to confirm the safety of fifteen (15±3) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms in adolescents. The study aims to demonstrate the safety profile of Prism, having no device-related serious adverse events (SAEs), consistent with findings in the adult population, throughout the course of Prism treatment in an adolescent population.",[27],"Post-Traumatic Stress Disorder in Adolescence",[29,30],"Neurofeedback","PTSD in adolescent","RECRUITING","2026-04-30",{"date":34,"type":35},"2026-05-05","ACTUAL",{"date":37,"type":35},"2025-06-11",{"date":39,"type":21},"2026-11-01",{"name":41,"class":42},"GrayMatters Health Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100605689","brief-videos-delivered-by-text-messages-as-a-public-health-intervention-for-ptsd-in-youth-100605689","NCT07165782","Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth","Brief Videos Delivered by Text Messages as a Public Health Intervention for PTSD in Youth: A Feasibility and Acceptability Randomized Trial","Inclusion Criteria:\n\n* Likely diagnosis of PTSD as indicated by a minimum score of 31 on the Post Traumatic Stress Disorder Checklist\n* Direct exposure to actual or threatened death, serious injury, or sexual violence or through witnessing, learning it happened to a close relation as assessed by the Life Events Checklist\n* Between 15 and 25 years old at time of enrolment\n* Access to a mobile phone and a data plan that allows them to receive text messages and videos\n* Live in Canada\n\nExclusion Criteria:\n\n* Presence of active suicidality, determined by items from the Patient Safety Screener\n* Active symptoms of psychosis, indicated by a brief Psychosis Screener Questionnaire\n* An inability to read and\u002For understand English","15 Years","25 Years",{"count":53,"type":21},98,[24],"The goal of this clinical trial is to learn if informational videos (the intervention) sent by text messages can help young people (age 15 - 25) manage symptoms of post traumatic stress disorder (PTSD). This is a small-scale trial to evaluate whether the intervention has potential to be effective, whether it is feasible to carry out a bigger study, and whether youth find the intervention acceptable.The main questions it aims to answer are:\n\n1. Does the intervention help youth reduce their symptoms of PTSD, anxiety, and depression, improve how well they function day-to-day, and lead to post-traumatic growth.\n2. Will it be possible to conduct a larger study on the intervention (e.g., are we able to attract participants to take part in the study; do participants follow through with the intervention and the study) and is the intervention acceptable to youth (e.g., do they watch the videos, and rate the videos as useful, interesting, understandable, and relevant)?\n\nResearchers will compare those who receive the intervention right away to those who wait to receive the intervention to see if there are differences between groups.\n\nVideos will teach youth about PTSD and provide the opportunity to practice strategies that have been shown to help with reduce symptoms of PTSD, such as exposure, reducing avoidance, social support, and coping strategies (e.g., changing your thoughts, deep breathing, and muscle relaxation).\n\nThe study is fully online. Participants will be randomly placed in one of two groups:\n\n1. Intervention Group: Gets three PTSD-related text messages per week for 10 weeks. They will also be asked to rate each of the videos on how helpful you found them.\n2. Waitlist Group: Does not receive text messages until AFTER the final surveys for the study are completed (i.e., 5 months), then will receive the intervention.\n\nEveryone will be asked to complete online surveys about their mental health and functioning 3 times during the study:\n\n* Beginning of the study\n* 10 weeks into the study\n* 3 months after the videos end (end of study)",[27,57,58],"Post-Traumatic Stress Disorder, PTSD","Post-Traumatic Stress Disorder in Youth",[60,61,62,63,64,65,66],"posttraumatic stress disorder","post-traumatic stress disorder","trauma","public health","rct","text message","video intervention","2025-09-03",{"date":69,"type":35},"2025-09-10",{"date":69,"type":21},{"date":72,"type":21},"2026-12-30",{"name":74,"class":75},"IWK Health Centre","OTHER",1]