An interventional study of Cognitive Processing Therapy in Stress Disorders, Post-Traumatic and Sexually Transmitted Infection (STI) Prevention, sponsored by Toronto Metropolitan University. Not yet recruiting at 2 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
The intervention will consist of 14 90-minute weekly virtual sessions of CPT with a study therapist. Session 1: Discuss sexual history/goals regarding PTSD and STBBI risk reduction, including reducing CAS, using medications to treat HIV/bacterial 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/challenge beliefs regarding safety, trust, power/control, 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/goals for progress regarding PTSD, substance use, \& STBBI risk reduction
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 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/adaptive beliefs, less cognitive/affective avoidance, \& more goal-directed approach behaviours.
Also known as: CPT
Condomless anal sex (CAS) with casual partners, based on response at 6 months.
Participants will indicate frequency of CAS and number of casual sex partners, defined as partners of less than a 6-month duration for 1) insertive and receptive anal sex and vaginal or frontal sex both with and without a condom, in the past 3 months.
Time frame: 3-months following final treatment session
PTSD Measures
PTSD Scale-5 (CAPS-5). The CAPS-5 will be our primary measure of PTSD. The CAPS-5 includes a lifetime trauma checklist and questions about stressor exposure, which will be used to ensure that participants meet the DSM-5 criterion of traumatic stressor criteria exposure that is required for diagnosis. The CAPS-5 yields a continuous measure of PTSD severity, as well as diagnostic status. The psychometric properties of the CAPS-5 have been well-established.
Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
Self-Report Measures - PTSD
PTSD. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a well-validated measure of PTSD severity. The Impact of Events - Revised scale will also be used to evaluate our mediator of avoidance of negative cognitions and affect and provide additional data on participants' trauma.
Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
Self-Report Measures - Sexual behavior
Self-report: Frequency and number of sexual partners
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
The Structured Clinical Interview for DSM-5 Disorders (SCID-5) will be used to determine whether participants meet diagnostic criteria for PTSD disorder or any other psychological disorder. A subset of 20% of randomly selected baseline assessments will be reviewed by a second diagnostician for reliability.
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
Laboratory specimens will be collected via blood tests, and throat and rectal swabs. We will also ask for self-report of HIV/STI incidence in the last 6 months.
Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
Self-Report Measures - Substance Use.
To assess substance use and dependence problems, we will use the well validated and highly reliable World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST).
Time frame: baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up
Qualitative Exit Interview
This is a structured interview that guides the participant through primary open-ended questions concerning their experience of the intervention. These questions are designed to solicit information of the acceptability of the intervention and the participant's satisfaction with intervention. A sample question is "Do you have any concerns about the program or recommendations for improvement?" The interview takes approximately 30 minutes to complete.
Time frame: post-intervention (an average of 16-18 weeks after baseline)
Plan to share: No
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Toronto Metropolitan University