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A Comparison of CPT Versus ART Versus WL

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ClinicalTrials.gov Identifier: NCT03384706
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Cincinnati VA Medical Center
Information provided by (Responsible Party):
Kathleen Chard, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Accelerated Resolution Therapy (ART) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: The assessors will remain blind to treatment condition throughout the study.
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive Processing Therapy (CPT) Versus Accelerated Resolution Therapy (ART) Versus Wait List (WL)
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. PTSD symptom severity [ Time Frame: Through study completion, an average of 15 months ]
    Combined Clinician-Administered PTSD Scale for DSM-IV and DSM-5 (CAPS-IV/CAPS-V)


Secondary Outcome Measures :
  1. Depression symptom severity [ Time Frame: Through study completion, an average of 15 months ]
    Patient Health Questionnaire-9 (PHQ-9)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384706


Contacts
Contact: Laura A Gilliam, PhD 513-861-3100 ext 6226 Laura.Gilliam@va.gov
Contact: Erica L Birkley, PhD 513-558-1919 birkleea@ucmail.uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Laura A Gilliam, PhD    513-861-3100 ext 6226    Laura.Gilliam@va.gov   
Contact: Erica L Birkley, PhD    513-558-1919    birkleea@ucmail.uc.edu   
Principal Investigator: Kathleen M Chard, PhD         
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Laura A Gilliam, PhD    513-861-3100 ext 6226    Laura.Gilliam@va.gov   
Contact: Erica L Birkley, PhD    513-558-1919    birkleea@ucmail.uc.edu   
Principal Investigator: Kathleen M Chard, PhD         
Sponsors and Collaborators
University of Cincinnati
Cincinnati VA Medical Center
Investigators
Principal Investigator: Kathleen M Chard, PhD Cincinnati VA Medical Center; University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Kathleen Chard, University of Cincinnati:

Responsible Party: Kathleen Chard, Director, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03384706     History of Changes
Other Study ID Numbers: 2017-1590
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Chard, University of Cincinnati:
posttraumatic stress disorder (PTSD)
Clinical Trial
Psychotherapy
Assessment
Effectiveness

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders