[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05233111":3,"trial-entities:NCT05233111":91,"trial-summary:NCT05233111":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":70,"locations":73,"central_contacts":83,"overall_officials":84,"references":89,"see_also_links":90},"NCT05233111","021-339","Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury","Prevention of Posttraumatic Stress: A RCT of Modified Brief Prolonged Exposure Therapy (Brief PE) During Inpatient Rehabilitation Post Spinal Cord Injury (SCI)","ENROLLING_BY_INVITATION","2026-08","2026-01","2026-01-22","2022-02-07","Baylor Research Institute","OTHER",false,"This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.","This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).",[19,20,21],"Spinal Cord Injuries","PTSD","Post-Traumatic Stress Disorder",[20,23,24,21],"SCI","Spinal Cord Injury","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},200,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Brief Prolonged Exposure Therapy","Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.",[38],"Brief Prolonged Exposure",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Treatment as Usual","This may include an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months.",[40],[44],{"measure":45,"description":46,"timeFrame":47},"Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5","Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms.","Baseline, 1 month, 3 months ,6 months",[49,52],{"measure":50,"description":51,"timeFrame":47},"Change in Patient Health Questionnaire-9","Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues.",{"measure":53,"description":54,"timeFrame":55},"Change in Generalized Anxiety Disorder-7 Item","Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety.","Time Frame: Baseline, 1 month, 3 months, 6 months","ALL","18 Years",null,{"inclusion":60,"exclusion":63,"raw_text":69},[61,62],"18 years of age or older","Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event",[64,65,66,67,68],"Patients in police custody","Not fluent in the English language","Severe cognitive impairment","Patients who are acutely suicidal","Patients with active psychosis","Inclusion Criteria:\n\n* 18 years of age or older\n* Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event\n\nExclusion Criteria:\n\n* Patients in police custody\n* Not fluent in the English language\n* Severe cognitive impairment\n* Patients who are acutely suicidal\n* Patients with active psychosis",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Kirstie A Jones","Dallas","Texas","75204","United States",{"lat":81,"lon":82},32.78306,-96.80667,[],[85],{"name":86,"affiliation":87,"role":88},"Mark B Powers, PhD","Baylor Scott and White Research Institute-Trauma","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[21,24],[],{"nct_id":4,"found":15,"summary":58,"prompt_version":58}]