- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812131
COPEWeb Training for Providers (COPEWeb)
January 11, 2024 updated by: VA Office of Research and Development
Web-Based Provider Training for Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPEWeb)
PTSD and substance use disorders (SUD) are two of the most common and debilitating mental health conditions afflicting military Veterans.
PTSD and SUD frequently co-occur and are associated with poorer treatment outcomes.
The investigators' team developed a trauma-focused intervention, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), which is identified by the VA as a gold standard of behavioral healthcare.
However, a critical barrier to ensuring that Veterans with co-occurring PTSD/SUD receive evidence-based treatment is a lack of provider training.
This project directly addresses this critical gap by developing a new web-based training program for providers (COPEWeb).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Background: PTSD is the most common mental health disorder among Veterans seeking treatment at Veterans Affairs (VA) hospitals, and more than half of Veterans with PTSD also meet criteria for a substance use disorder (SUD).
To address the critical need for PTSD/SUD treatment, members of the investigative team developed Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), an evidence-based, integrated, trauma-focused treatment identified by the VA as a gold standard of behavioral healthcare.
Randomized controlled trials among Veterans demonstrate COPE's efficacy in significantly reducing PTSD and substance use.
The majority of Veterans with PTSD/SUD prefer integrated treatment.
Significance/Impact: At present, there is a critical shortage of clinicians trained to deliver COPE.
Traditional in-person workshops are inefficient and costly.
A poll of VA PTSD/SUD Specialists across the country found that 96.9% are interested in receiving COPE training and 99.1% would use a web-based training for COPE if available.
A web-based resource for providers is ideal, as it can be rapidly disseminated, is easily accessible, and provides a significant amount of information in a standardized way.
This project will directly address this critical gap in provider training to improve the care of Veterans with comorbid PTSD/SUD, enhance treatment delivery using innovative in-session provider assistance tools, and enhance knowledge of cost-benefit of technology-enhanced training.
COPEWeb may be particularly useful for providers in rural clinic settings where mental health training is less accessible.
This proposal has the potential for high military relevance and an immediate impact on dissemination and uptake of COPE, as well as a long-term impact on the overall health of the millions of Veterans suffering from co-occurring PTSD/SUD.
Innovation: A new web-based provider training for COPE will be developed along with a highly innovative provider assistance toolkit to guide clinicians in real-time during sessions to enhance delivery and fidelity to the protocol and reduce provider burden.
A panel of national VA experts and dissemination leaders will develop a best practice VA dissemination guideline on disseminating web-based provider trainings.
The proposed project has the potential to significantly enhance provider training and increase patient access to evidence-based care.
Furthermore, COPEWeb has the potential to serve a novel role in disaster planning to ensure mental health care providers are equipped to address the anticipated post-pandemic needs of Veterans given the rise in post-traumatic stress and alcohol/drug use during the pandemic.
Specific Aims: This project aims to 1) develop a new web-based training protocol and innovative delivery aid system to strengthen providers' delivery of COPE to treat Veterans with PTSD/SUD with a high level of fidelity and competence, and 2) compare the COPEWeb training to in-person training on measures of knowledge, satisfaction, and behavior (i.e., fidelity).
The cost effectiveness of web-based vs. in-person training will be examined.
Methodology: The proposed methods and timeline for the development of COPEWeb are based on the team's prior success developing other widely-used provider training protocols (e.g., PEWeb, CBTIWeb).
COPEWeb will be built and refined over the course of three strategic phases: content development, alpha-testing, and beta-testing.
Following beta testing, the investigators will compare COPEWeb to in-person training among clinicians.
Ongoing assessment will obtain qualitative and quantitative data on measures of provider satisfaction, knowledge, and behavior.
Implementation/Next Steps: In collaboration with the investigators' operations partners, VA leadership, and EBP Coordinators, COPEWeb will be rapidly disseminated to mental health providers to increase adoption of evidence-based treatment for PTSD/SUD and improve the quality of mental health care for Veterans and the nation.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sudie E Back, PhD
- Phone Number: (843) 792-9383
- Email: Sudie.Back@va.gov
Study Contact Backup
- Name: Stacey S Sellers, MS
- Phone Number: 206703 (843) 789-6703
- Email: Stacey.Sellers@va.gov
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29401-5703
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
Principal Investigator:
- Sudie E. Back, PhD
-
Contact:
- Sudie E Back, PhD
- Phone Number: 843-792-9383
- Email: Sudie.Back@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- currently a provider in a behavioral health field (e.g., psychology, psychiatry) in the VA
- at least 18 years old
- English speaking
- able to consistently obtain reliable internet access
- willing to attend a 2-day "live" in-person (or virtual) COPE training if randomly assigned to that condition
- willing to engage in a standardized patient assessment after training
- has no prior formal training in the COPE therapy
Exclusion Criteria:
- received prior training in COPE
- not a provider in the behavioral health field in the VA
- non-English speaking
- lack of reliable internet access
- younger than 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COPEWEb
online COPEWeb training
|
COPE training delivered via online COPEWEb to providers
|
Active Comparator: COPE In person
COPE training delivered in person
|
COPE training provided in person to providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBM Computer Usability Satisfaction Questionnaires (CSUQ)
Time Frame: Through study completion, an average of 8 weeks
|
The CSUQ is a 19-item Likert-type (7-point [strongly agree to strongly disagree]) questionnaire that provides an overall usability satisfaction score along with subscales that measure program usefulness, information quality, and interface quality.
The CSUQ measure and subscales have good reliability, sensitivity, and validity.
|
Through study completion, an average of 8 weeks
|
COPE Knowledge Acquisition Test (CKAT)
Time Frame: Change from baseline to study completion, an average of 8 weeks
|
The CKAT will be completed at pre- and post-training.
The 20-item measure will be scored and the percent of items answered correctly (rated from 0 to 100% correct) will be assessed.
Higher scores represent greater knowledge.
|
Change from baseline to study completion, an average of 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sudie E. Back, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 5, 2027
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Estimated)
January 15, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 21-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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