[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06367764":3,"trial-entities:NCT06367764":107,"trial-summary:NCT06367764":111},{"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":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":44,"secondary_outcomes":49,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":98,"overall_officials":102,"references":105,"see_also_links":106},"NCT06367764","79658","A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations","LGBTQIA+ Initiative for Empowerment, Support, Coping, and PTSD Education: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations","RECRUITING","2028-06","2025-04","2025-04-24","2024-08-01","Stanford University","OTHER",false,"The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer\u002Fquestioning, intersex, asexual\u002Faromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:\n\n* Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?\n* Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?\n* Do stress from stigma and discrimination and drug\u002Falcohol use change the impact of the treatment on PTSD symptoms?\n* Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?\n* Do LGBTQIA+ patients complete these treatments?\n\nStudy participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment.","This study will compare two PTSD treatments that are known to work: Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT). PTSD treatments have not been tested among LGBTQIA+ people. The study is trying to learn which treatment(s) work the best for LGBTQIA+ people in real world settings. This study will help guide clinical decision-making and the selection of PTSD treatment by health care organizations, clinicians, and patients based on what works best for LGBTQIA+ people.\n\nThe study will investigate which treatments work better in reducing PTSD symptoms among LGBTQIA+ people. The study will identify if minority stress (e.g., experiences of stigma and discrimination) and use of drugs or alcohol will moderate the effects of the interventions on PTSD symptoms. This study is investigating if both treatments improve depression symptoms and improve quality of life, and which treatments patients complete. The study is also examining if these treatments are effective for all individuals in the study, and if the effects of treatment are different among: 1) cisgender sexual minority men, cisgender sexual minority women, gender expansive or non-binary individuals, transgender women, transgender men, 2) participants who live in urban versus rural or suburban areas, and 3) racial and ethnic minority LGBTQIA+ participants.",[19],"PTSD",[19,21,22,23,24,25,26],"Therapy","LGBTQ","Depression","Comparative Effectiveness Trial","Substance Use","Minority Stress","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},400,"ESTIMATED",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Cognitive Processing Therapy","Cognitive Processing Therapy teaches cognitive restructuring skills to help clients change beliefs and process emotions related to a traumatic event or events.",[37],{"type":36,"name":41,"description":42,"armGroupLabels":43},"STAIR Narrative Therapy","STAIR Narrative Therapy teaches coping skills (e.g., for emotional regulation, interpersonal relationships, everyday stress) and includes a narrative trauma-focused component.",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)","The PCL-5 is a validated measure of self-report DSM-5 symptoms of PTSD. The self-report rating scale is 0-4 for each symptom, with higher scores indicating greater symptom severity.","Months 0 (baseline), 3, 6, and 12",[50,53,56,60],{"measure":51,"description":52,"timeFrame":48},"Change in Depression Measured by Patient Health Questionnaire (PHQ-9)","The PHQ-9 is a 9-item measure of depression consistent with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. The self-report rating scale is 0-3 for each symptom, with higher scores indicating greater symptom severity. PHQ-9 has demonstrated good psychometric properties including criterion, construct, and external validity, and sensitivity (88%) and specificity (88%) for major depressive disorder.",{"measure":54,"description":55,"timeFrame":48},"Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales","The self-report 26-item WHOQOL-BREF was multi-nationally developed to assess QOL related to physical health, psychological well-being, social relationships, and environment. The Social Relationships scale assesses facets of quality of life related to personal relationships, social support, and sexual activity. The Environment scale assesses facets related to quality of life including physical safety and security, accessibility and quality of health and social care, and participation in social and leisure opportunities.",{"measure":57,"description":58,"timeFrame":59},"Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)","The 13-item self-report STTS-R comprises two scales (Satisfaction with Therapy and Satisfaction with Therapist), both with documented reliability and validity.","Months 3, 6, and 12",{"measure":61,"description":62,"timeFrame":63},"Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions","Treatment dropout is defined as completion of \\\u003C 8 sessions, corresponding to the median effective dose. The number of sessions completed will be identified through mandatory session notes completed by clinicians for each study visit.","Across intervention","ALL","18 Years",null,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria:\n\n1. 18 years of age or older\n2. Currently live in California\n3. Ability to understand study procedures and to comply with them for the entire length of the study\n4. Ability to understand a written informed consent document and the willing to sign it\n5. Ability to speak and read English or Spanish\n6. Identify as a sexual and\u002For gender minority\n7. Score 33 or higher on the PTSD Checklist-5 (PCL-5)\n8. Interest in getting treatment for PTSD\n9. Not be in another concurrent psychotherapy treatment (group or individual) for PTSD (psychotherapy treatment for non-PTSD conditions is allowed).\n10. Able to attend treatment sessions in person in San Francisco or have access to a device that allows for treatment via videoconferencing.\n\nExclusion Criteria:\n\n1. Contraindication to any study-related procedure or assessment\n2. Clinically significant impairment which interferes with ability to fully participate in the study (including symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, or other disorders)\n3. Active suicidal intent",[72,73],"ADULT","OLDER_ADULT",[75,89],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Palo Alto","California","94304","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Annesa Flentje, PhD","CONTACT","415-502-4859","lgbtqia_study@ucsf.edu",{"lat":87,"lon":88},37.44188,-122.14302,{"facility":90,"status":8,"city":91,"state":77,"zip":92,"country":79,"contacts":93,"geoPoint":95},"UCSF Alliance Health Project","San Francisco","94103",[94],{"name":82,"role":83},{"lat":96,"lon":97},37.77493,-122.41942,[99],{"name":100,"role":83,"phone":101,"email":85},"Annesa P Flentje, PhD","650-497-7112",[103],{"name":100,"affiliation":13,"role":104},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This interventional study will compare two behavioral therapies in 400 participants. It aims to find out which treatment works best for LGBTQIA+ individuals.","completed","PTSD Treatments for Sexual and Gender Minority Populations","This study is comparing two established therapies, Cognitive Processing Therapy and STAIR Narrative Therapy, to see how well they treat post-traumatic stress disorder (PTSD) in adults who identify as sexual and\u002For gender minorities (LGBTQIA+). The goal is to understand if these treatments reduce PTSD symptoms, improve quality of life, and lessen depression in this community. Researchers also want to see if factors like stress from discrimination or drug\u002Falcohol use affect treatment outcomes, and if different groups within the LGBTQIA+ community respond differently. The study plans to enroll 400 participants and is currently unclear on its recruitment status.","Participants will be followed for 12 months, with assessments at months 0 (baseline), 3, 6, and 12.",97,"Not specified in the trial record.","Not stated in the trial record.",[37,41],"v2"]