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Behavioral Intervention

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

N/A
Waitlist Available
Research Sponsored by Toronto Metropolitan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptoms meeting the criteria for PTSD based on the CAPS diagnostic interview
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention (an average of 16-18 weeks after baseline)
Awards & highlights

Summary

"This trial aims to develop a new therapy to help reduce sexually transmitted and blood-borne infections among gay, bisexual, queer, and other men who have sex with men. These men are at a higher

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
As this intervention involves psychotherapy rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort discussing traumatic experiences during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Condomless Anal Sex with casual partners, based on response at 6 months.
Secondary outcome measures
Change in Clinical diagnosis and Severity of Mental Health Symptoms
Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis
PTSD Measures
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive Processing TherapyExperimental Treatment1 Intervention
The intervention will consist of 15 1-hour 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 8-13: Discuss/challenge beliefs regarding safety, trust, power/control, esteem, & intimacy Session 14: Identify how participant's changed beliefs may affect sexual decision making, CAS, and substance use in sexual situations Session 15: Discuss relapse prevention/goals for progress regarding PTSD, substance use, & STBBI risk reduction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Processing Therapy
2016
N/A
~3400

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Who is running the clinical trial?

Toronto Metropolitan UniversityLead Sponsor
88 Previous Clinical Trials
16,286 Total Patients Enrolled
~17 spots leftby Aug 2025
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