[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714083":3,"trial-entities:NCT07714083":96,"trial-summary:NCT07714083":100},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":90,"references":94,"see_also_links":95},"NCT07714083","H-45022","Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress","Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial","NOT_YET_RECRUITING","2030-07","2026-07","2026-07-20","2026-10","Boston University","OTHER",false,"Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.\n\nThe proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.","This study will occur in two phases.\n\nPhase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).\n\nPhase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.",[19],"Post Traumatic Stress Disorder",[21,22,23,24],"Cognitive Processing Therapy (CPT)","Lived experience stress","Lived Experience Adapted Protocol (LEAP)","Veterans","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},52,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Standard CPT","CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself. Worksheets and assignments are given between each session.",[38],"Standard Cognitive Therapy Processing (CPT)",{"type":34,"name":40,"description":41,"armGroupLabels":42},"CPT-LEAP","CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.",[43],"Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)",[45],{"measure":46,"description":47,"timeFrame":48},"Post traumatic stress disorder symptoms (PTSD)","Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5). The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.","immediately after treatment, 3 months",[],"ALL","18 Years",null,{"inclusion":54,"exclusion":60,"raw_text":68},[55,56,57,58,59],"Current diagnosis of PTSD","Self-identification as a sexual or gender minority (SGM) individual","Endorsement of SGM stress experiences with moderate distress","For patients who take psychiatric medication, stable dose one month prior to enrollment","Reside in Massachusetts.",[61,62,63,64,65,66,67],"Current active suicidal or homicidal ideation with intent or plan","Unstable bipolar disorder\u002Fcurrent mania","Unstable psychotic disorder\u002Fcurrent psychosis","Current severe substance use that warrants immediate medical attention","Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures","Past completion of CPT or current trauma-focused treatment","Unwillingness to consent to audio or video recording of assessment and treatment sessions","Inclusion Criteria:\n\n* Current diagnosis of PTSD\n* Self-identification as a sexual or gender minority (SGM) individual\n* Endorsement of SGM stress experiences with moderate distress\n* For patients who take psychiatric medication, stable dose one month prior to enrollment\n* Reside in Massachusetts.\n\nExclusion Criteria:\n\n* Current active suicidal or homicidal ideation with intent or plan\n* Unstable bipolar disorder\u002Fcurrent mania\n* Unstable psychotic disorder\u002Fcurrent psychosis\n* Current severe substance use that warrants immediate medical attention\n* Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures\n* Past completion of CPT or current trauma-focused treatment\n* Unwillingness to consent to audio or video recording of assessment and treatment sessions",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"VA Boston Healthcare System","Jamaica Plain","Massachusetts","02130","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Cara Herbitter, PhD, MPH","CONTACT","857-364-6528","Cara.Herbitter@va.gov",{"lat":86,"lon":87},42.30982,-71.12033,[89],{"name":81,"role":82,"phone":83,"email":84},[91],{"name":81,"affiliation":92,"role":93},"Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This study will involve two phases. In Phase 2, participants will be randomly assigned to receive either standard CPT or CPT-LEAP, with 26 participants in each group.","completed","Cognitive Processing Therapy for PTSD in Sexual and Gender Minority Individuals","This study is testing two types of Cognitive Processing Therapy (CPT) for Post Traumatic Stress Disorder (PTSD) in sexual or gender minority individuals. One is standard CPT, and the other is CPT-LEAP, which is adapted to address stress from lived experiences. The goal is to see if CPT-LEAP better helps with PTSD symptoms. You may be able to join if you are 18 or older, identify as a sexual or gender minority, have a current PTSD diagnosis, experience moderate stress from lived experiences, and live in Massachusetts. If you take psychiatric medication, your dose must be stable for one month before joining. The study is currently unclear on its recruitment status and plans to enroll 52 participants.","Your PTSD symptoms will be measured immediately after treatment and again 3 months later.",117,"Not specified in the trial record.","Not stated in the trial record.",[35,40],"v2"]