{"id":"nct:NCT06885996","kind":"trial","title":"Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence","authors":["University of Calgary"],"author_count":1,"year":2025,"published":"2025-03-20","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT06885996","source_url":"https://clinicaltrials.gov/study/NCT06885996","archive_url":"https://space-kitty.com/papers/nct:NCT06885996","updated":"2026-09-08","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"The goal of this randomized controlled trial is to evaluate the efficacy of psilocybin administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce post-traumatic stress disorder (PTSD) symptom burden in adult (aged 18-65) survivors of intimate partner violence (IPV). This trail will test the following 2 aims: AIM 1 : To compare the efficacy of a therapeutic psilocybin dose at improving outcomes on the PCL-5 and CAPS-5 as compared to an active control psilocybin dose in IPV survivors with chronic PTSD. AIM 2: To evaluate the efficacy of psilocybin on quality of life, cognitive function, motor ability, depression, anxiety, and cognitive flexibility. Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \\[25mg\\] or low dose psilocybin \\[1mg\\]) * Complete 5-6 weekly sessions of ACT * Repeat outcome measures at 1-week, 4 weeks, 3 months (online questionnaires only), and 6 months post-psilocybin administration.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Post Traumatic Stress Disorder PTSD","Intimate Partner Violence (IPV)"],"details":{"acronym":"PsiPTSD","status":"NOT_YET_RECRUITING","phase":"PHASE2","study_type":"INTERVENTIONAL","enrollment":76,"sponsor":"University of Calgary","conditions":["Post Traumatic Stress Disorder PTSD","Intimate Partner Violence (IPV)"],"interventions":["DRUG: Psilocybin"],"start_date":"2026-10-01","start_date_type":"ESTIMATED","primary_completion_date":"2028-08-01","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"psychiatric-therapeutics","name":"Novel Psychiatric Therapeutics","domain_slug":"neuroscience"}],"cited_in_dossiers":[]}