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A Comparison of CPT Versus ART Versus WL

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Accelerated Resolution Therapy (ART)
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder (PTSD), Clinical Trial, Psychotherapy, Assessment, Effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Cincinnati
  • Cincinnati VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Cognitive Processing Therapy (CPT)

Accelerated Resolution Therapy (ART)

Wait List Control

Arm Description

PTSD Psychotherapy CPT will be implemented using the Cognitive-Only version, excluding the trauma account.

PTSD Psychotherapy

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).

Outcomes

Primary Outcome Measures

PTSD symptom severity
Combined Clinician-Administered PTSD Scale for DSM-IV and DSM-5 (CAPS-IV/CAPS-V)

Secondary Outcome Measures

Depression symptom severity
Patient Health Questionnaire-9 (PHQ-9)

Full Information

First Posted
July 20, 2017
Last Updated
November 29, 2022
Sponsor
University of Cincinnati
Collaborators
Cincinnati VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03384706
Brief Title
A Comparison of CPT Versus ART Versus WL
Official Title
A Comparison of Cognitive Processing Therapy (CPT) Versus Accelerated Resolution Therapy (ART) Versus Wait List (WL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Cincinnati VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder (PTSD), Clinical Trial, Psychotherapy, Assessment, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study will examine the effectiveness of Cognitive Processing Therapy (CPT) as compared to Accelerated Resolution Therapy (ART) and a Waitlist (WL) control using a Randomized, Cross-Over Design. 280 participants will be randomly assigned to ART, CPT or WL. Upon completion of the WL condition, participants will be re-randomized to ART or CPT.
Masking
Outcomes Assessor
Masking Description
The assessors will remain blind to treatment condition throughout the study.
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy (CPT)
Arm Type
Active Comparator
Arm Description
PTSD Psychotherapy CPT will be implemented using the Cognitive-Only version, excluding the trauma account.
Arm Title
Accelerated Resolution Therapy (ART)
Arm Type
Experimental
Arm Description
PTSD Psychotherapy
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Resolution Therapy (ART)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptom severity
Description
Combined Clinician-Administered PTSD Scale for DSM-IV and DSM-5 (CAPS-IV/CAPS-V)
Time Frame
Through study completion, an average of 15 months
Secondary Outcome Measure Information:
Title
Depression symptom severity
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Through study completion, an average of 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Chard, PhD
Organizational Affiliation
Cincinnati VA Medical Center; University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of CPT Versus ART Versus WL

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