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

Stress Disorders, Post-Traumatic Clinical Trial

— CPT-T  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463431
• Other study ID #: REB 2024-NIL
• Secondary ID: 151412
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 27, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: Toronto Metropolitan University
• Contact: Jane Cao, BA
• Phone: 4169795000
• Email: hivprevmanager[@]torontomu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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). In 2020, GBM accounted for 46.6% of new HIV diagnoses in Canada. 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. Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men. Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM. 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 is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy.

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 15 1-hour sessions of an integrated cognitive-behavioural approach using Cognitive Processing Therapy (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, and PTSD-related avoidance of negative thoughts and feelings.

This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• engaging in CAS with a man in the last three months with a casual (<6 months duration) male partner

• symptoms meeting the criteria for PTSD based on the CAPS diagnostic interview

• engaging in substance use in the past three months

Exclusion Criteria:

• if a 15-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

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Metropolitan University	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condomless Anal Sex with casual partners, based on response at 6 months.	Participants will indicate frequency of and number of casual sexual 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.	6-month follow-up
Secondary	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.	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	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.	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	Self-Report Measures - Sexual behavior	Self-report: Frequency and number of sexual partners	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	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.	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	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.	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	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).	baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
Secondary	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.	post-intervention (an average of 16-18 weeks after baseline)