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Cognitive Processing Therapy for PTSD (CF-CPT Trial)

N/A

Waitlist Available

Led By Tara Ellen Galovski, PhD MA BS

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

Must not have

Serious drug or alcohol abuse that requires immediate medical attention (e.g. inpatient care)

Current mania

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not need immediate medical help for drug or alcohol use.

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I am currently experiencing a manic episode.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-Administered PTSD Scale-5 (CAPS) (assessing change over time)

Inventory of Psychosocial Functioning (assessing change over time)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met