120 Participants Needed

Psychotherapy for PTSD

(PERPP Trial)

LE
GF
Overseen ByGreg Fonzo, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how cognitive processing therapy (CPT), a form of trauma-focused psychotherapy, can change brain function and improve the ability to feel positive emotions in people with PTSD (posttraumatic stress disorder). Participants will either start therapy immediately or after a short delay to compare outcomes. This trial suits individuals who have experienced a traumatic event and have had PTSD symptoms for at least three months. Participants should be comfortable with MRI scans and ready for several assessments.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research in PTSD treatment.

Will I have to stop taking my current medications?

Yes, if you are currently taking regular psychiatric medications like antidepressants, you will need to stop, except for as-needed benzodiazepine or opiate medication no more than three times per week, or short-duration stimulant medication for ADHD that can be skipped within 24 hours of study visits.

What prior data suggests that cognitive processing therapy is safe for PTSD?

Research has shown that Cognitive Processing Therapy (CPT) is generally safe for treating PTSD. One study found that only 6.9% of participants stopped CPT, suggesting most find it manageable. Evaluations also indicate that military and veteran patients who received CPT experienced improvements in PTSD and depression symptoms. No major reports of harmful side effects exist, making CPT a well-tolerated option for managing PTSD symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about Cognitive Processing Therapy (CPT) for PTSD because it offers a structured, cognitive-behavioral approach that helps individuals reframe and process traumatic memories, which is different from many traditional therapies that focus more on exposure. While standard PTSD treatments, like Prolonged Exposure Therapy and Eye Movement Desensitization and Reprocessing, often emphasize confronting trauma directly, CPT emphasizes changing thought patterns to reduce the emotional impact of those memories. This approach can be particularly appealing for individuals who find direct exposure to trauma distressing. Additionally, CPT is typically delivered over a shorter, more intensive period, potentially providing quicker relief of symptoms.

What is the effectiveness track record for cognitive processing therapy in treating PTSD?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive, effectively treats PTSD. One study found that individuals who underwent CPT experienced a 14-point reduction in PTSD symptoms on a symptom scale. These improvements were significant and persisted for 17 to 34 weeks after treatment. Other studies confirm that CPT helps reduce symptoms such as depression and suicidal thoughts, which often accompany PTSD. A review of multiple studies also supports that CPT provides lasting benefits for people with PTSD.12367

Who Is on the Research Team?

GA

Gregory A Fonzo, PhD

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with chronic PTSD, who have experienced symptoms for at least 3 months. Participants must be able to undergo brain scans (fMRI) and not currently use regular psychiatric medications, except certain as-needed drugs. Those with a history of psychosis, bipolar disorder, substance dependence, recent suicide attempts or ideation, metal implants incompatible with fMRI, pregnancy or exposure therapy are excluded.

Inclusion Criteria

Able and willing to undergo functional magnetic resonance imaging (fMRI)
I am willing to undergo frequent tests and possibly start treatment later.
I speak and understand English well enough to follow study instructions.
See 1 more

Exclusion Criteria

You are currently receiving a treatment that might interfere with the study results.
I have had a mild-to-moderate brain injury without any penetrating injury.
I have undergone psychotherapy with exposure or cognitive restructuring in the past year.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo clinical and neurobiological assessment with fMRI during reward processing paradigms

1 week

Treatment

Participants receive cognitive processing therapy (CPT) with an assigned study therapist

6-8 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms and brain function post-treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Processing Therapy
Trial Overview The study examines the impact of Cognitive Processing Therapy (CPT), an established treatment for PTSD on how the brain processes rewards and positive emotions after trauma. It involves repeated assessments and participation in a delayed treatment group to observe changes in brain function over time.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate TreatmentExperimental Treatment1 Intervention
Group II: Delayed TreatmentPlacebo Group1 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:
🇪🇺
Approved in European Union as Cognitive Processing Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

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

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.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 ...
Cognitive Processing Therapy for Posttraumatic Stress ...The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...
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.
Cognitive Processing Therapy for PTSDTo date, CPT has been shown to improve common comorbid symptoms and clinical correlates of PTSD such as depression (12,33), suicidal ideation (34), health- ...
5.pubmed.ncbi.nlm.nih.govpubmed.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.
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.
NCT04230668 | Cognitive Processing Therapy (CPT) for ...A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.
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