Psychotherapy for PTSD

(PERPP Trial)

Overseen by Gregory A Fonzo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Must not be taking: Antidepressants

Disqualifiers: Psychosis, Bipolar, Substance dependence, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.

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.

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 effectively used in various settings, including the Department of Veterans Affairs healthcare system. ^{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 focuses on helping individuals challenge and change unhelpful beliefs related to their trauma, using a structured approach that includes education, exposure, and cognitive components. Unlike some other treatments, CPT can be delivered in both group and individual formats, making it versatile for different settings and populations. ^{1 2 5 6 7}

Research Team

Gregory A Fonzo, PhD

Principal Investigator

The University of Texas at Austin

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cognitive Processing Therapy (Behavioral Intervention)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Findings from Research

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]

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) 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) 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) 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 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

Dissemination and experience with cognitive processing therapy. [2022]

2. 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]

3. 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]

4. 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]

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

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

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

Cognitive processing therapy for sexual assault victims. [2022]

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]