Cognitive Processing Therapy vs. Relaxation Training for PTSD

Overseen By Sarah Pridgen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must be taking: Psychotropic medications

Disqualifiers: Recent trauma, Suicidal, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to reduce PTSD (posttraumatic stress disorder) symptoms. One group will undergo Cognitive Processing Therapy (CPT), which includes 10 virtual therapy sessions over five days. The other group will participate in relaxation training, with five virtual sessions in five days. The trial aims to determine which treatment is more effective and how they function. Individuals diagnosed with PTSD, who have experienced past trauma, are interested in these treatments, and reside in Illinois may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore new therapeutic options for PTSD.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must have been on a stable dose of any psychotropic medication for at least one month before starting the trial.

What prior data suggests that these treatments are safe for PTSD?

Research has shown that Cognitive Processing Therapy (CPT) is generally easy for people to handle. Studies found that only 6.9% of participants stopped the treatment, suggesting that most can complete the therapy without major issues.

CPT has successfully helped people with PTSD and related issues like depression and suicidal thoughts. It has lasting positive effects on PTSD symptoms and overall mental health, indicating that the therapy is safe and effective for many.

Relaxation Training (RT) is another common method that helps manage stress and anxiety. It is considered safe and is widely used for various mental health conditions. Reports of negative effects are rare, making it a low-risk option for most participants.

Overall, both treatments in this clinical trial have a history of being safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they offer unique approaches compared to traditional options like medication or talk therapy. Cognitive Processing Therapy (CPT) stands out as it focuses on changing painful negative beliefs related to the trauma, potentially leading to deeper emotional healing. Relaxation Training (RT), on the other hand, emphasizes reducing physical tension and stress, which can be a safe and simple way to alleviate PTSD symptoms. Both approaches offer non-medication alternatives that could provide new avenues for people who haven't found relief with standard treatments.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare Cognitive Processing Therapy (CPT) with Relaxation Training (RT) for treating PTSD. Research has shown that CPT, which participants in this trial may receive, effectively treats PTSD. Several studies have found that people who undergo CPT experience a significant reduction in PTSD symptoms. For example, one study noted a decrease of about 14 points on a PTSD symptom scale, marking a substantial improvement. Another study found that the benefits of CPT lasted for months after the treatment ended. Overall, CPT has proven to help many people with PTSD, providing lasting relief from symptoms.

In contrast, Relaxation Training (RT), another treatment option in this trial, is often used to help manage stress but lacks the same strong evidence for reducing PTSD symptoms specifically. While relaxation techniques can be calming and may help with anxiety, CPT has a more established record for directly addressing PTSD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with PTSD who are interested in intensive therapy. Participants must have experienced a traumatic event, be stable on any psychotropic meds for at least a month, and commit to daily sessions over one week. Exclusions include recent trauma, unstable medical conditions, current legal actions related to the trauma, unmanaged psychosis or mania, recent substance abuse treatment needs, and sensory impairments.

Inclusion Criteria

I have been diagnosed with PTSD by a professional using a specific scale.

Are fluent in English

Have experienced a Criterion A traumatic event during their lifetime

Exclusion Criteria

I haven't been on a steady dose of mental health medication for a month.

I experienced a traumatic event within the last month.

They are currently suicidal or homicidal (i.e., plan and intent)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 1-week virtual massed Cognitive Processing Therapy (CPT) or 5-day virtual relaxation training (RT) to reduce PTSD symptoms

1 week

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Relaxation Training

Trial Overview

The study compares two virtual treatments: massed Cognitive Processing Therapy (CPT) delivered over one week versus Relaxation Training (RT) given the same way. It aims to assess changes in PTSD symptoms and understand psychological mechanisms that may influence treatment success.

How Is the Trial Designed?

Group I: Cognitive Processing Therapy (CPT) Experimental Treatment 1 Intervention

Group II: Relaxation Training (RT) Active Control 1 Intervention

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?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

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]

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) 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]

Cognitive processing therapy (CPT) was found to be effective for treating PTSD in a diverse group of 259 veterans, with 76.1% of those who completed the therapy reporting significant improvement in their symptoms.

The study indicated that while CPT is broadly applicable across different demographics and trauma types, individual characteristics largely influenced treatment outcomes, and no specific predictors were identified for varying responses to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting response to cognitive processing therapy: Does trauma history matter? Roberge, EM., Weinstein, HR., Bryan, CJ.[2022]

Citations

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