A Comparison of CPT Versus ART Versus WL

NCT03384706 | Completed

• 1 other identifier: 2017-1590
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder (PTSD); Clinical Trial; Psychotherapy; Assessment; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression symptom severity

  Through study completion, an average of 15 months

Study Arms (3)

Cognitive Processing Therapy (CPT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Processing Therapy (CPT)

Accelerated Resolution Therapy (ART)

EXPERIMENTAL

PTSD Psychotherapy

Behavioral: Accelerated Resolution Therapy (ART)

Wait List Control

NO INTERVENTION

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).

Interventions

Cognitive Processing Therapy (CPT) 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.

Cognitive Processing Therapy (CPT)

Accelerated Resolution Therapy (ART) 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.

Accelerated Resolution Therapy (ART)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• May have posttraumatic stress disorder (PTSD)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Cincinnati VA Medical Center: collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kathleen M Chard, PhD

  Cincinnati VA Medical Center; University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will remain blind to treatment condition throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: December 27, 2017
• Study Start: September 6, 2017
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)