A Comparison of CPT Versus ART Versus WL

A Comparison of Cognitive Processing Therapy (CPT) Versus Accelerated Resolution Therapy (ART) Versus Wait List (WL)

The purpose of this research study is to compare the effectiveness of two treatments for the symptoms of Posttraumatic Stress Disorder (PTSD) with a no therapy, wait-list control condition. The two treatments are Cognitive Processing Therapy (CPT) as compared to Accelerated Resolution Therapy (ART). Both have been found to be effective with veterans and civilians in prior studies but they have never been compared to one another. Participants will be 280 males and females ages 18 and older who meet criteria for PTSD (or subthreshold PTSD). PTSD is a condition that can occur after a trauma experience such as combat, sexual abuse, physical abuse, or natural disasters.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy (CPT); Behavioral: Accelerated Resolution Therapy (ART)

Detailed Description

Objective(s): The primary aim of this study is to examine the effectiveness of two treatments for the symptoms of Posttraumatic Stress Disorder (PTSD) with a no therapy, wait list control condition. The two treatments are Cognitive Processing Therapy (CPT) as compared to Accelerated Resolution Therapy (ART). Additional related symptoms of depression, anger, sleep, and physical health will also be assessed. The study will involve both civilians and veterans seeking outpatient therapy for PTSD. Data will be obtained via clinician structured interviews and self-report measures.

Research Design: Participants will be recruited from the Cincinnati VA Medical Center, Trauma Recovery Center (TRC), and at the University of Cincinnati (UC) Health Stress Center located in Cincinnati, Ohio. All eligible participants will be randomized to receive CPT, ART, or Wait List (WL) condition. For participants who are randomized to the WL condition, following a period of seven weeks will be randomized into one of the two active treatment conditions, CPT or ART. Participants in the two active treatment conditions will complete an assessment at pre-treatment, post-treatment, 3 month, and 1 year follow-up.

Methodology: Participants will include 280 males and females ages 18 and older who meet criteria for PTSD (or subthreshold PTSD). The investigators will contact potential participants to determine eligibility for the study assessing inclusionary and exclusionary criteria. All eligible participants will then be asked to complete a pre-treatment assessment prior to being assigned their study treatment (CPT or ART or WL). Participants will receive a full course of outpatient CPT or ART depending on their assigned study treatment. Once the participant and treating clinician determine that therapy has been fully completed, participants will complete a post-treatment assessment. Follow-up assessments will then be completed 3-months and 1-year following the completion of therapy.

At each assessment participants will be asked to complete a series of self- and clinic-reported measures that include assessments of PTSD symptoms, depression, general mental health, pain, sleep habits, and health care utilization.

Findings: Not applicable at this time.

Clinical Relationships: The investigators anticipate that understanding the comparative effectiveness between CPT and ART therapies will provide necessary information for care provided to civilians and veterans suffering from PTSD.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• May have posttraumatic stress disorder (PTSD)

Exclusion Criteria:

• Meet criteria for unmedicated bipolar, mania, or unmedicated psychotic disorders
• Meet criteria for a substance use disorder requiring detoxification treatment
• Have active suicidal or homicidal intent with (a) plan(s) and (a) means
• Have a medical condition that will interfere with twice weekly therapy sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Processing Therapy (CPT); PTSD Psychotherapy CPT will be implemented using the Cognitive-Only version, excluding the trauma account.	Behavioral: Cognitive Processing Therapy (CPT); CPT looks at the impact the traumatic event has had on your life and helps you to examine and change unhelpful thoughts and feelings related to the event, yourself, others and the world. CPT will be conducted in 5-15, 60 minute sessions held once or twice a week.
Experimental: Accelerated Resolution Therapy (ART); PTSD Psychotherapy	Behavioral: Accelerated Resolution Therapy (ART); ART, like CPT also involves processing thoughts and feelings related to the event, but does this in a different way relying more on visualization or imagination rather than talking. ART will be conducted in 5-15, 60 minute sessions held once or twice a week.
No Intervention: Wait List Control; Wait List control will include a 7 week minimal attention control period with weekly check-in calls to ensure that the participant has not experienced any significant worsening in their symptoms that might require interventions, (e.g. suicidal intent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptom severity	Combined Clinician-Administered PTSD Scale for DSM-IV and DSM-5 (CAPS-IV/CAPS-V)	Through study completion, an average of 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptom severity	Patient Health Questionnaire-9 (PHQ-9)	Through study completion, an average of 15 months

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Cincinnati VA Medical Center
• Investigators: Principal Investigator: Kathleen M Chard, PhD, Cincinnati VA Medical Center; University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Assessment; Clinical Trial; Effectiveness; Psychotherapy; posttraumatic stress disorder (PTSD)
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2017-1590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No