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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder (PTSD)?

Cognitive Processing Therapy (CPT) has been shown to significantly reduce PTSD symptoms in various settings, including among women in residential treatment and sexual assault survivors, with improvements maintained for months. It is also widely used by the Department of Veterans Affairs, demonstrating solid improvements in PTSD and depression symptoms among veterans. ^{1 2 3 4 5}

Is cognitive processing therapy (CPT) safe for humans?

Cognitive processing therapy (CPT) is widely regarded as a safe treatment for post-traumatic stress disorder (PTSD) and has been implemented in various settings, including the Department of Veterans Affairs, with positive outcomes. It is considered a first-line treatment for PTSD and has been shown to be effective in reducing symptoms without significant safety concerns. ^{1 2 3 5 6}

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

Cognitive Processing Therapy (CPT) is unique because it focuses on helping individuals challenge and change unhelpful beliefs related to their trauma, using a structured approach that includes education, exposure, and cognitive components. It can be delivered in both group and individual formats, making it versatile for different settings and populations. ^{1 2 3 4 7}

What is the purpose of this trial?

This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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 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) 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]

References

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

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]

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

Dissemination and experience with cognitive processing therapy. [2022]

3. 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]

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

Cognitive processing therapy for sexual assault victims. [2022]

5. England 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. [2023]

6. England 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. [2019]

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

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