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

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).

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.

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 used effectively in various settings, including among military personnel and sexual assault survivors, without significant safety concerns reported. ^{1 2 3 4 5}

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

Cognitive Processing Therapy (CPT) is unique because it combines education, exposure, and cognitive components to help individuals process and challenge their beliefs about traumatic events, which is different from other therapies that may focus solely on exposure or medication. It is often delivered in a group format, making it efficient for treating multiple individuals simultaneously, and has been shown to be effective for various populations, including military personnel and sexual assault survivors. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for PTSD?

Cognitive Processing Therapy (CPT) is an evidence-based treatment that has been shown to effectively reduce PTSD symptoms in various settings, including among military personnel and veterans. Studies indicate that CPT can lead to significant improvements in PTSD symptoms, with many patients experiencing a reduction in symptoms after completing the therapy. ^{1 2 5 8 9}

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

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) 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]

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) 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]

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]

Citations

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

Predicting response to cognitive processing therapy: Does trauma history matter? [2022]

3. England pubmed.ncbi.nlm.nih.gov

In-office, in-home, and telehealth cognitive processing therapy for posttraumatic stress disorder in veterans: a randomized clinical trial. [2022]

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

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

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

Dissemination and experience with cognitive processing therapy. [2022]

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

Cognitive processing therapy for sexual assault victims. [2022]

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Patterns and temporal precedence of symptom change during cognitive processing therapy for military sexual trauma-related posttraumatic stress disorder. [2022]