A Comparison of CPT Versus ART Versus WL

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384706
• Other study ID #: 2017-1590
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: November 2022
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Cincinnati VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Depression symptom severity	Patient Health Questionnaire-9 (PHQ-9)	Through study completion, an average of 15 months