Cognitive Processing Therapy for PTSD and Sexually Transmitted Infections

(CPT-T Trial)

Not yet recruiting at 1 trial location

Overseen By Trevor A Hart, Ph.D, CPsych

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Toronto Metropolitan University

Disqualifiers: Psychotic, Bipolar, Disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cognitive Processing Therapy (CPT) to reduce the risk of sexually transmitted infections (STIs) and HIV among gay, bisexual, and queer men who have sex with men and experience PTSD symptoms. The therapy addresses both PTSD and substance use, which link to risky sexual behaviors that can increase STI risk. Participants will attend 14 weekly virtual sessions focusing on trauma and risky sexual behavior. Men living in Ontario or Quebec, who have recently had anal sex without a condom, and show PTSD symptoms may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to innovative therapies for PTSD and STI prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have psychotic or bipolar disorders that are not well-managed by medications, you may be excluded from the trial.

What prior data suggests that Cognitive Processing Therapy is safe for treating PTSD and reducing STBBI risks among GBM?

Research has shown that Cognitive Processing Therapy (CPT) is a well-researched treatment for PTSD. Studies indicate that CPT effectively reduces PTSD symptoms, even in individuals requiring significant support. In one study, only 6.9% of participants discontinued the therapy early, suggesting that most find it manageable. Another study found that CPT led to lasting improvements in PTSD symptoms over time. These findings suggest that CPT is not only effective but also generally safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Processing Therapy (CPT) for PTSD and sexually transmitted infections (STIs) because it integrates mental health treatment with sexual health education, which is not typical in standard care. Unlike traditional PTSD treatments, which often focus solely on trauma, this CPT approach also addresses how PTSD can impact sexual decision-making and STI risk. Additionally, the virtual delivery method through 14 weekly sessions makes it more accessible and convenient for participants, potentially increasing engagement and effectiveness. By targeting both cognitive and behavioral aspects, CPT offers a comprehensive approach that could improve both mental health and reduce STI risk.

What evidence suggests that Cognitive Processing Therapy might be an effective treatment for PTSD and reducing STBBI risk among GBM?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial will receive, can effectively reduce PTSD symptoms. Many studies have found that it significantly decreases PTSD symptoms and related issues like depression, with benefits lasting up to six months. This therapy helps individuals change negative thoughts and feelings related to trauma. For gay, bisexual, queer, and other men who have sex with men (GBM), addressing PTSD with CPT may also reduce risky behaviors that can lead to sexually transmitted infections (STIs) and substance use. By focusing on trauma and its effects on sexual health, CPT aims to lower the risk of STIs in this group. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 14 weekly 90-minute virtual sessions of Cognitive Processing Therapy (CPT) to treat PTSD and reduce STBBI risks

14 weeks

14 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of PTSD, substance use, and sexual behavior

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Cognitive Processing Therapy Experimental Treatment 1 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

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

Openspace Clinic

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Cognitive Processing Therapy (CPT) significantly improved PTSD and depression symptoms in 19 sexual assault survivors after 12 weekly group sessions, with benefits maintained for 6 months post-treatment.

In contrast, a comparison group of 20 individuals who waited for therapy showed no improvement, highlighting the efficacy of CPT in treating PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. Resick, PA., Schnicke, MK.[2022]

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ...

The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7272815/

Cognitive Processing Therapy for Posttraumatic Stress ...

In‐home CPT had the lowest drop‐out rates (21%), followed by telehealth (33%) and in‐office treatment (44%). However, there were no significant differences in ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy

Dozens of clinical trials have demonstrated CPT's efficacy reducing PTSD and related symptoms (e.g., Asmundson et al., 2019, Monson et al., 2006, Resick et al., ...

4.

withpower.com

withpower.com/trial/phase-sexually-transmitted-diseases-7-2024-c11a4

Cognitive Processing Therapy for PTSD and Sexually ...

Studies found significant improvements in PTSD and depression symptoms after CPT, with benefits lasting up to six months.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11800015/

Cognitive Processing Therapy for Posttraumatic Stress ...

This randomized clinical trial investigates the safety and efficacy of cognitive processing therapy for posttraumatic stress disorder in a ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ...

This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

7.

ptsd.va.gov

ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD

Program evaluation data from intensive treatment programs serving military and Veteran patients receiving CPT have shown improvements in PTSD and depression ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ...

CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32964375/

A Comparison of Cognitive Processing Therapy and ...

To compare the outcomes of Seeking Safety (SS) and cognitive processing therapy (CPT) in veterans with PTSD in a specialty clinic of an urban VA ...