Cognitive Processing Therapy to Treat PTSD and Sexually Transmitted Infections Among Men Who Have Sex With Men

Official title

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

Overview

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). The present study will provide preliminary feasibility and acceptability data for a novel and innovative STI/HIV 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. This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk.

Interventions

• Behavioral Cognitive Processing Therapy
  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 unr

Primary outcome measures

• Condomless anal sex (CAS) with casual partners, based on response at 6 months. [Time frame: 3-months following final treatment session]

Secondary outcome measures (7)

• PTSD Measures [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Self-Report Measures - PTSD [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Self-Report Measures - Sexual behavior [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Change in Clinical diagnosis and Severity of Mental Health Symptoms [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Self-Report Measures - Substance Use. [Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up]
• Qualitative Exit Interview [Time frame: post-intervention (an average of 16-18 weeks after baseline)]

Eligibility criteria

Inclusion criteria

• Live in Ontario or Quebec (able to travel to Toronto Metropolitan University or CLSC de Cote-des-Neiges, respectively)
• Identify as a man
• Are over 18 years of age
• Have had anal sex without a condom with a person assigned male at birth in the past 3 months
• Have experienced symptoms consistent with a diagnosis of PTSD
• Are able to read, speak, and understand English

Exclusion criteria

• if a 14-session protocol is deemed inappropriate for their treatment needs (e.g., psychotic or bipolar disorders not well-managed by medications)
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Canada · 2 centers

• Toronto Metropolitan University — Toronto
• McGill University — Montreal

Publications

• Shoptaw S, Frosch D. Substance abuse treatment as HIV prevention for men who have sex with men. AIDS Behav. 2000;4(2):193-203.
• Parsons JT, Kutnick AH, Halkitis PN, Punzalan JC, Carbonari JP. Sexual risk behaviors and substance use among alcohol abusing HIV-positive men who have sex with men. J Psychoactive Drugs. 2005 Mar;37(1):27-36. doi: 10.1080/02791072.2005.10399746. PMID 15916249
• Koblin BA, Husnik MJ, Colfax G, Huang Y, Madison M, Mayer K, Barresi PJ, Coates TJ, Chesney MA, Buchbinder S. Risk factors for HIV infection among men who have sex with men. AIDS. 2006 Mar 21;20(5):731-9. doi: 10.1097/01.aids.0000216374.61442.55. PMID 16514304
• Lambert G, Cox J, Hottes TS, Tremblay C, Frigault LR, Alary M, Otis J, Remis RS; M-Track Study Group. Correlates of unprotected anal sex at last sexual episode: analysis from a surveillance study of men who have sex with men in Montreal. AIDS Behav. 2011 Apr;15(3):584-95. doi: 10.1007/s10461-009-9605-3. PMID 20033763
• Tan RKJ, Phua K, Tan A, Gan DCJ, Ho LPP, Ong EJ, See MY. Exploring the role of trauma in underpinning sexualised drug use ('chemsex') among gay, bisexual and other men who have sex with men in Singapore. Int J Drug Policy. 2021 Nov;97:103333. doi: 10.1016/j.drugpo.2021.103333. Epub 2021 Jun 24. PMID 34175526
• Elkington KS, Bauermeister JA, Zimmerman MA. Psychological distress, substance use, and HIV/STI risk behaviors among youth. J Youth Adolesc. 2010 May;39(5):514-27. doi: 10.1007/s10964-010-9524-7. Epub 2010 Mar 14. PMID 20229264
• Semple SJ, Strathdee SA, Zians J, McQuaid JR, Patterson TL. Drug assertiveness and sexual risk-taking behavior in a sample of HIV-positive, methamphetamine-using men who have sex with men. J Subst Abuse Treat. 2011 Oct;41(3):265-72. doi: 10.1016/j.jsat.2011.03.006. Epub 2011 May 8. PMID 21550758
• Benight CC, Bandura A. Social cognitive theory of posttraumatic recovery: the role of perceived self-efficacy. Behav Res Ther. 2004 Oct;42(10):1129-48. doi: 10.1016/j.brat.2003.08.008. PMID 15350854

Identifiers

NCT: NCT06463431 · REB 2024-251 · 151412 · 152308

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗