A Comparison of CPT Versus ART Versus WL

NCT ID: NCT03384706

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2021-03-15

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Processing Therapy (CPT)

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

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy (CPT)

Intervention Type: BEHAVIORAL

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)

PTSD Psychotherapy

Group Type: EXPERIMENTAL

Accelerated Resolution Therapy (ART)

Intervention Type: BEHAVIORAL

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cincinnati VA Medical Center

OTHER_GOV

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Chard

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen M Chard, PhD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati VA Medical Center; University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-1590

Identifier Type: -

Identifier Source: org_study_id