Cognitive Processing Therapy for PTSD and Sexually Transmitted Infections
(CPT-T Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Toronto Metropolitan University

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for gay, bisexual, queer men and other men who have sex with men (GBM) who are experiencing PTSD symptoms and have engaged in condomless anal sex and substance use recently. Participants must speak English well enough to understand the study measures. Men with severe mental health conditions not managed by medication or those unable to commit to a 15-session treatment plan are excluded.

Inclusion Criteria

I have been diagnosed with PTSD.

Engaging in substance use in the past three months

I have had unprotected sex with a casual male partner in the last three months.

Exclusion Criteria

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

If a 15-session protocol is deemed inappropriate for their treatment needs (e.g., psychotic or bipolar disorders not well-managed by medications)

Treatment Details

Interventions

Cognitive Processing Therapy (Behavioral Intervention)

Trial OverviewThe trial tests Cognitive Processing Therapy (CPT), aiming to treat PTSD and reduce sexually transmitted infections among GBM. It involves 15 one-hour sessions combining CPT with risk reduction counseling. The main focus is on reducing condomless anal sex with casual partners, alongside monitoring PTSD symptoms, substance use, and trauma-related avoidance behaviors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Cognitive Processing TherapyExperimental Treatment1 Intervention

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