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Cognitive Processing Therapy for PTSD (CF-CPT Trial)

N/A
Recruiting
Led By Shannon M. Kehle-Forbes, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.
Awards & highlights

CF-CPT Trial Summary

This trial will compare the efficacy of cognitive processing therapy (CPT) to cognitive processing therapy with case formulation (CF-CPT) in treating PTSD among US Veterans.

Who is the study for?
This trial is for US Veterans with PTSD who are not currently experiencing severe mental health issues like active suicidal thoughts, homicidal tendencies, mania, psychosis, or serious substance abuse needing immediate attention. They shouldn't be in another trauma-focused therapy but can continue stable psychiatric medications.Check my eligibility
What is being tested?
The study compares two methods of treating PTSD: standard Cognitive Processing Therapy (CPT) and a personalized version that includes Case Formulation (CF-CPT). It aims to see if CF-CPT improves psychosocial functioning and quality of life more than CPT alone over treatment and follow-up periods.See study design
What are the potential side effects?
While specific side effects are not listed for these therapies, psychological interventions may sometimes cause temporary increases in distress due to discussing traumatic events or changes in mood and behavior as individuals work through their experiences.

CF-CPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered PTSD Scale-5 (CAPS) (assessing change over time)
Inventory of Psychosocial Functioning (assessing change over time)
Secondary outcome measures
Beck Suicidal Ideation Scale (assessing change over time)
Brief Addiction Monitor (assessing change over time)
DSM-5 Cross-cutting symptom measure (CCSM) (assessing change over time)
+18 more

CF-CPT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Case Formulation plus Cognitive Processing TherapyExperimental Treatment1 Intervention
The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.
Group II: Cognitive Processing TherapyActive Control1 Intervention
CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,028 Total Patients Enrolled
Shannon M. Kehle-Forbes, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
2 Previous Clinical Trials
102 Total Patients Enrolled
Tara Ellen Galovski, PhD MA BSPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Media Library

Case Formulation plus Cognitive Processing Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04407767 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Case Formulation plus Cognitive Processing Therapy, Cognitive Processing Therapy
Post-Traumatic Stress Disorder Clinical Trial 2023: Case Formulation plus Cognitive Processing Therapy Highlights & Side Effects. Trial Name: NCT04407767 — N/A
Case Formulation plus Cognitive Processing Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04407767 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many total participants can this clinical trial accommodate?

"To undertake this research, 256 qualified individuals are needed to participate in the trial. Participants may submit their application from either Phoenix VA Health Care System in Arizona or Southeast Louisiana Veterans Health Care System located in Louisiana."

Answered by AI

What goals are scientists hoping to accomplish through this clinical experiment?

"This experiment is measuring change in Clinician-Administered PTSD Scale-5 (CAPS), Well-Being Inventory (WBI) and PTSD Checklist-DSM-5 (PCL - 5) over a 30 day period; post treatment, at session 6 and 3 months following. Additionally, the State Trait Anxiety Index will be used to assess individual's state of mind between baseline and follow up visits. The WBI consists of 21 sections with 126 questions/statements related to vocation, finances, health and social relationships while the PCL - 5 is a self report measure assessing 20 symptoms associated with PTSD yielding 4 subsc"

Answered by AI

Are there any US-based venues conducting this trial?

"8 sites have been approved to recruit participants for this medical trial, such as Phoenix VA Health Care System in Arizona and Southeast Louisiana Veterans Health Care System in Louisiana. Additionally, there are other 6 operating centres scattered across the US."

Answered by AI

Is this clinical trial currently accepting new participants?

"Yes, clinicaltrials.gov's information attests to the fact that this study is actively seeking out patients. It was first put up on March 15th 2021 and updated last April 1st 2022. This trial requires 256 subjects across 8 separate sites."

Answered by AI

Who else is applying?

What site did they apply to?
Salem VA Medical Center, Salem, VA
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Case Formulation Approach to Cognitive Processing Therapy
2021. "A Case Formulation Approach to Cognitive Processing Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04407767.
All > Ptsd Houston
~30 spots leftby Sep 2024
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