Clinical trial NCT03384706: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder (PTSD)
Clinical Trial
Psychotherapy
Assessment
Effectiveness
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Cincinnati VA Medical Center
First posted: 2017-12-27
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD symptom severity
timeFrame: Through study completion, an average of 15 months
Secondary outcomes:
measure: Depression symptom severity
timeFrame: Through study completion, an average of 15 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati VA Medical Center; University of Cincinnati
name: Kathleen M Chard, PhD
role: PRINCIPAL_INVESTIGATOR
References: