Cognitive Processing Therapy for PTSD and Sexually Transmitted Infections

(CPT-T Trial)

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

56 Participants Needed

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.

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 data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for PTSD and sexually transmitted infections?

Research shows that Cognitive Processing Therapy (CPT) is effective in reducing PTSD symptoms in sexual assault survivors and veterans with military sexual trauma. Studies found significant improvements in PTSD and depression symptoms after CPT, with benefits lasting up to six months. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) safe for humans?

Cognitive Processing Therapy (CPT) has been used safely in various studies for treating PTSD, particularly in veterans with military sexual trauma. These studies did not report any significant safety concerns, suggesting that CPT is generally safe for humans. ^{1 4 5 6 7}

How is Cognitive Processing Therapy (CPT) different from other treatments for PTSD?

Cognitive Processing Therapy (CPT) is unique because it focuses on changing negative thought patterns related to trauma through education, exposure, and cognitive components, and it has been shown to effectively reduce PTSD symptoms and trauma-related guilt, especially in cases involving sexual trauma. ^{1 2 3 4 5}

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)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Resolution of trauma-related guilt following treatment of PTSD in female rape victims: a result of cognitive processing therapy targeting comorbid depression? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of cognitive processing therapy for veterans with PTSD related to military sexual trauma. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for male veterans with military sexual trauma-related posttraumatic stress disorder. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Cognitive Processing Therapy for PTSD Related to Military Sexual Trauma in Veterans: A Review. [2020]