Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

Overseen By Michael Osborne, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Beta-blockers, High-intensity statins

Disqualifiers: Stroke, Seizure, Alcohol use disorder, 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: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Processing Therapy (CPT), a type of talk therapy, can assist people with PTSD and reduce their risk of heart disease. Researchers aim to determine if CPT can lower inflammation and improve heart-related functions by reducing stress. Participants will either receive the therapy or join a waitlist for it. Individuals who have experienced a traumatic event, exhibit PTSD symptoms, and possess heart disease risk factors like high blood pressure or diabetes may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of how CPT can benefit those with PTSD and heart disease risk factors.

Will I have to stop taking my current medications?

The trial requires that you do not change your psychiatric or cardiovascular medications within 4 weeks before starting, meaning you should be on a stable regimen. However, if you are taking certain CVD medications like beta-blockers or high-intensity statins, you may not be eligible to participate.

What prior data suggests that Cognitive Processing Therapy is safe for PTSD?

A previous study found that Cognitive Processing Therapy (CPT) was well-tolerated by participants. Reports show that patients, including military personnel and veterans, experienced improvements in PTSD and depression symptoms without major safety concerns. Another study found that people who underwent CPT had lasting positive changes in their PTSD symptoms over time. No major negative effects were reported, suggesting that CPT is safe for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cognitive Processing Therapy (CPT) is unique because it specifically targets the way trauma affects thinking patterns, helping individuals with PTSD reframe and process traumatic events. Unlike other treatments for PTSD, such as medication or exposure therapy, CPT focuses on changing the negative thoughts and beliefs that develop after trauma. Researchers are excited about CPT because it empowers patients to understand and change their thought processes, potentially leading to long-lasting improvements in mental health. This therapy can offer a structured and effective alternative for those who might not respond well to conventional treatments.

What evidence suggests that Cognitive Processing Therapy is effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive, effectively treats PTSD. Studies have found that CPT can significantly reduce PTSD symptoms, with one study noting an average drop of 14 points in symptom severity. CPT has also helped people with PTSD in various groups, including military and veteran communities, by improving both PTSD and depression symptoms. A review of many studies confirmed CPT's long-lasting benefits across various outcomes, proving its effectiveness as a PTSD treatment. Overall, CPT is a dependable therapy for those dealing with PTSD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with PTSD to see if Cognitive Processing Therapy (CPT) can lower their risk of heart disease. Participants should be diagnosed with PTSD but not currently receiving CPT. There's no mention of specific exclusions, so general health requirements likely apply.

Inclusion Criteria

Ability to understand and sign informed consent

I have experienced a traumatic event and suffer from PTSD symptoms.

I have or am at high risk for heart artery disease.

Exclusion Criteria

I have a history of stroke, brain surgery, or seizures.

I have a neurological or systemic inflammatory disease and am on anti-inflammatory treatment.

Moderate/severe alcohol/substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete surveys, brain and peripheral imaging, and resting measures of autonomic function

1 week

1 visit (in-person)

Treatment

Participants receive Cognitive Processing Therapy (CPT) via telehealth

12 weeks

Weekly sessions (virtual)

Post-treatment Assessment

Participants attend a post-treatment visit with the same assessments as baseline

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy

Trial Overview The study tests whether CPT, a common treatment for PTSD, can reduce the risk of cardiovascular disease by affecting inflammation and autonomic function, potentially influenced by stress-related neural activity.

How Is the Trial Designed?

Group I: Cognitive processing therapy Experimental Treatment 1 Intervention

12 week treatment period of cognitive processing therapy followed by a post-treatment visit.

Group II: Control waitlist Active Control 1 Intervention

Participants randomized to waitlist are offered CPT upon completion of the post-treatment visit.

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?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

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]

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) effectively reduced PTSD symptoms in a 74-year-old woman veteran, indicating its potential utility for older adults with PTSD.

The case study suggests that CPT can be applied to older adults without significant modifications, highlighting its adaptability as a first-line treatment for PTSD in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivered as Described: A Successful Case of Cognitive Processing Therapy With an Older Woman Veteran With PTSD. Reuman, L., Davison, EH.[2023]

Cognitive Processing Therapy (CPT) effectively reduced PTSD symptoms in a study of 18 patients, with 15 participants showing statistically significant improvements in their symptom scores.

The study highlights the successful adaptation of the CPT protocol to address specific barriers faced by trauma survivors, demonstrating its potential for broader implementation in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. Zappert, LN., Westrup, D.[2019]

Cognitive processing therapy (CPT) is an effective treatment for PTSD in veterans, but many do not complete the full program, often receiving only four sessions instead of the full 12, highlighting the need for a more efficient treatment format.

A study involving 270 veterans used a fractional factorial design to identify the most effective components of CPT, aiming to create a shorter version that could reduce dropout rates and improve treatment accessibility for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Sripada, RK., Peterson, CL., Dziak, JJ., et al.[2023]

This study aims to evaluate the efficacy of Cognitive Processing Therapy (CPT) for treating PTSD in Japanese patients through a 16-week trial involving 58 participants, comparing CPT combined with usual treatment against usual treatment alone.

The primary outcome will be measured using the Clinician-Administered PTSD Scale, with an expected effect size of 1.4, indicating that CPT may significantly improve PTSD symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. Ito, M., Horikoshi, M., Resick, PA., et al.[2019]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

3. 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.

4. 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

6. 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.

7. 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 ...