Psychotherapy for PTSD

(PERPP Trial)

Overseen By Greg Fonzo, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Antidepressants

Disqualifiers: Psychosis, Bipolar, Substance dependence, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Immediate Treatment Experimental Treatment 1 Intervention

Those individuals randomized to immediate treatment will commence individual cognitive processing therapy (CPT) with an assigned study therapist, following the completion of baseline procedures.

Group II: Delayed Treatment Placebo Group 1 Intervention

Individuals randomized to the delayed treatment condition will be informed after randomization that their treatment will start in 6-8 weeks (the approximate period it will take for individuals in the immediate treatment arm to complete CPT and post-treatment assessments).

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?

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.

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 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]

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) 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]

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.

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 ...

The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

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

To 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.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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04230668

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.