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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (an average of 16-18 weeks after baseline), 3-month follow-up, 6-month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Condomless Anal Sex with casual partners, based on response at 6 months.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Processing Therapy

2016

N/A

~4030

0 / 1Eligibility criteria met