[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551695":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":33,"responsibleParty":74,"collaborators":21,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":21,"enrollmentInfo":87,"targetDuration":21,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":106,"whyStopped":21,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Toronto Metropolitan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Processing Therapy","EXPERIMENTAL","The intervention will consist of 14 90-minute weekly virtual sessions of CPT with a study therapist.\n\nSession 1: Discuss sexual history\u002Fgoals regarding PTSD and STBBI risk reduction, including reducing CAS, using medications to treat HIV\u002Fbacterial STBBIs, \\& providing education about the benefits of using PrEP Session 2: Review the cognitive model for CPT and the index trauma Sessions 3-7: Address problematic appraisals of the index trauma, maladaptive thoughts, and the experience and expression of natural emotions. Teach cognitive intervention skills to facilitate cognitive \\& emotional change Sessions 8-12: Discuss\u002Fchallenge beliefs regarding safety, trust, power\u002Fcontrol, esteem, \\& intimacy Session 13: Identify how participant's changed beliefs may affect sexual decision making, CAS, and substance use in sexual situations Session 14: Discuss relapse prevention\u002Fgoals for progress regarding PTSD, substance use, \\& STBBI risk reduction",[13],"Behavioral: Cognitive Processing Therapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","We propose a conceptual model for the relationship between PTSD, substance use, \\& sexual risk behaviour wherein using substances to avoid posttraumatic cognitions \\& affect leads to risky sexual behaviour through impaired safer sex negotiation. These mechanisms are consistent with the theory underlying CPT. Behaviourally, substance use (and potentially risky sexual behaviour) is negatively reinforced through avoiding unwanted negative affect. Cognitively, PTSD-based predictions may generate unrealistic risk appraisals that contribute to sexual risk. CPT addresses these specified pathways by a) identifying how trauma leads to maladaptive beliefs about the self, others, \\& the future, b) cognitive interventions to address these beliefs, \\& c) an overall trauma-focused orientation that addresses cognitive, affective \\& behavioural avoidance, using cognitive restructuring to lead to more realistic\u002Fadaptive beliefs, less cognitive\u002Faffective avoidance, \\& more goal-directed approach behaviours.",[9],[20],"CPT",null,[23,29],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Jane Cao, BA","CONTACT","4169795000","552179","RISE.study@torontomu.ca",{"name":30,"role":25,"phone":26,"phoneExt":31,"email":32},"Trevor A Hart, Ph.D, CPsych","556192","trevor.hart@torontomu.ca",[34,52],{"facility":5,"status":21,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Toronto","Ontario","M5B 1Y3","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-79.39864,43.70643,{"lat":44,"lon":43},[47,49],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":48},"hivprevmanager@torontomu.ca",{"name":50,"role":25,"phone":26,"phoneExt":27,"email":51},"Allison L Kirschbaum, PhD","akirschbaum@torontomu.ca",{"facility":53,"status":21,"city":54,"state":55,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"McGill University","Montreal","Quebec","H3A 0G4",{"type":41,"coordinates":58},[59,60],-73.58781,45.50884,{"lat":60,"lon":59},[63,67,69,71],{"name":64,"role":25,"phone":65,"phoneExt":21,"email":66},"Pierre-Paul Tellier, MD","514-891-0830","pierre-paul.tellier@mcgill.ca",{"name":68,"role":25,"phone":21,"phoneExt":21,"email":21},"Nate Fuks",{"name":64,"role":70,"phone":21,"phoneExt":21,"email":21},"SUB_INVESTIGATOR",{"name":72,"role":73,"phone":21,"phoneExt":21,"email":21},"Nate Fuks, PhD","PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Trevor Hart","Professor","100551695","cognitive-processing-therapy-to-treat-ptsd-and-sexually-transmitted-infections-among-men-who-have-sex-with-men-100551695",false,"NCT06463431","Cognitive Processing Therapy to Treat PTSD and Sexually Transmitted Infections Among Men Who Have Sex With Men","A Trial for An Integrated Cognitive Behavioural Therapy to Treat PTSD and Sexually Transmitted Infections Among Gay, Bisexual, and Other Men Who Have Sex With Men","CPT-T","Inclusion Criteria:\n\n* Live in Ontario or Quebec (able to travel to Toronto Metropolitan University or CLSC de Cote-des-Neiges, respectively)\n* Identify as a man\n* Are over 18 years of age\n* Have had anal sex without a condom with a person assigned male at birth in the past 3 months\n* Have experienced symptoms consistent with a diagnosis of PTSD\n* Are able to read, speak, and understand English\n\nExclusion Criteria:\n\n* if a 14-session protocol is deemed inappropriate for their treatment needs (e.g., psychotic or bipolar disorders not well-managed by medications)\n* if either our assessors or therapists identify that a participant's ability to respond to study measures is compromised by mental or physical disabilities or inability to speak and understand English","MALE","18 Years",{"count":88,"type":89},56,"ESTIMATED","INTERVENTIONAL",[92],"NA","Gay, bisexual, queer, and other men who have sex with men (GBM) continue to bear a disproportionate burden of the sexually transmitted and blood-borne infections (STBBI), largely attributable to efficient transmission during condomless anal sex (CAS; Baggaley et al., 2010). In 2022, GBM accounted for 38.1% of new HIV diagnoses in Canada (Public Health Agency of Canada, 2023). Incidence of syphilis, chlamydia and gonorrhea have risen among men who have sex with men (MSM), especially among HIV+ GBM living in Canadian urban centres, including Toronto and Quebec (Public Health Agency of Canada, 2022). Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men (Roberts et al., 2010). Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM (O'Cleirigh, 2019). Despite the strong association between PTSD and STBBI risk among GBM, no studies have examined the efficacy of PTSD treatment on STBBI risk among GBM. PTSD may also increase substance use in sexual situations, another risk factor for STBBIs among GBQM (Semple et al., 2011; Elkington et al., 2010). Substance use tends to follow PTSD because alcohol and other substances are often used to self-medicate trauma symptoms (as an avoidant coping strategy) in interpersonal situations (Tan et al., 2021). Alcohol and substance use in sexual situations are consistent risk factors for CAS among Canadian GBQM (Lambert et al., 2011), and are associated with higher HIV incidence. Due to consistent data linking substance use to STBBI risk, it has been suggested that incorporating alcohol and substance use treatment into sexual risk reduction counselling (Koblin et al., 2006; Parsons et al., 2005; Shoptaw \\& Frosch, 2000) may increase the efficacy of STBBI prevention efforts for GBQM. PTSD is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy (CPT; Benight \\& Bandura, 2004; Monson \\& Shnaider, 2014; Watkins et al., 2018).\n\nThe present study will provide preliminary feasibility and acceptability data for a novel and innovative STI\u002FHIV prevention intervention for GBQM. This intervention builds upon empirically supported treatments for PTSD, including PTSD-related substance use, by adding risk reduction counselling to reduce sexually transmitted infections (STI) and HIV sexual risk behaviour. The present study will provide trial data for a novel and innovative STBBI prevention psychotherapy for GBM that could be administered by mental health providers across Canada. The intervention will consist of 14 90-minute sessions of an integrated cognitive-behavioural approach using CPT to treat PTSD and to reduce STBBI risks among GBQM. The primary outcome will be condomless anal sex with casual partners. The secondary outcomes will be PTSD prevalence, trauma symptoms, problematic substance use, sexual risk, and PTSD-related avoidance of negative thoughts and feelings.\n\nThis psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk.",[95,96],"Stress Disorders, Post-Traumatic","Sexually Transmitted Infection (STI) Prevention",[9,98,99,100,101,102,103,104,105],"men who have sex with men","gay bisexual queer men","gay men","post traumatic stress disorder","Cognitive Behavioral Therapy","sexually transmitted blood borne infections","sexual risk","prevention","NOT_YET_RECRUITING","2025-02-07",{"date":109,"type":110},"2025-02-11","ACTUAL",{"date":112,"type":89},"2025-03-31",{"date":114,"type":89},"2026-08",{"name":5,"class":6},2]