Posttraumatic Stress DisorderNCT03384706
A Comparison of CPT Versus ART Versus WL
A study testing Cognitive Processing Therapy (CPT) and Accelerated Resolution Therapy (ART) in people with Posttraumatic Stress Disorder, run by University of Cincinnati at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy (CPT) and Accelerated Resolution Therapy (ART)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2017to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- May have posttraumatic stress disorder (PTSD)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
About this study
Official title: A Comparison of Cognitive Processing Therapy (CPT) Versus Accelerated Resolution Therapy (ART) Versus Wait List (WL)
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.
Read the 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
- Being tested
- Cognitive Processing Therapy (CPT), Accelerated Resolution Therapy (ART)
- Keywords
- posttraumatic stress disorder (PTSD), Clinical Trial, Psychotherapy, Assessment, Effectiveness
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy (CPT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | PTSD Psychotherapy CPT will be implemented using the Cognitive-Only version, excluding the trauma account. Receives: Behavioral: Cognitive Processing Therapy (CPT) |
| Accelerated Resolution Therapy (ART) | Experimental | PTSD Psychotherapy Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity
Combined Clinician-Administered PTSD Scale for DSM-IV and DSM-5 (CAPS-IV/CAPS-V)
Measured: Through study completion, an average of 15 months
Secondary outcomes (1)
Depression symptom severity
Patient Health Questionnaire-9 (PHQ-9)
Measured: Through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start6 Sep 2017
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Cincinnati VA Medical Center
- Responsible party
- Principal investigator, Kathleen Chard, University of Cincinnati
- Investigators
- Kathleen M Chard, PhD, Principal investigator, Cincinnati VA Medical Center; University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384706
- Sponsor's protocol ID
- 2017-1590
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2017
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive Processing Therapy (CPT) Versus Accelerated Resolution Therapy (ART) Versus Wait List (WL)
- ClinicalTrials.gov ID
- NCT03384706
- Acronym / sponsor ID
- 2017-1590
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder (PTSD), Clinical Trial, Psychotherapy, Assessment, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Cincinnati VA Medical Center
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | Behavioral: Cognitive Processing Therapy (CPT)PTSD Psychotherapy CPT will be implemented using the Cognitive-Only version, excluding the trauma account. |
| Accelerated Resolution Therapy (ART) | Experimental | Behavioral: Accelerated Resolution Therapy (ART)PTSD Psychotherapy |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- May have posttraumatic stress disorder (PTSD)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Processing Therapy (CPT) |
| 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. | Behavioural | Accelerated Resolution Therapy (ART) |
Primary outcome
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)
1 secondary outcome
Depression symptom severity
Time frame: Through study completion, an average of 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Chard, PhD principal investigator
Cincinnati VA Medical Center; University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy (CPT) and Accelerated Resolution Therapy (ART) in people with Posttraumatic Stress Disorder, run by University of Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity (time frame: Through study completion, an average of 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.