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COPEWeb Training for Providers (COPEWeb)

Primary Purpose

PTSD, Substance Use Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPEWeb online training
COPE In Person
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for PTSD focused on measuring PTSD, substance use disorders, training, providers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ralph H. Johnson VA Medical Center, Charleston, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COPEWEb

COPE In person

Arm Description

online COPEWeb training

COPE training delivered in person

Outcomes

Primary Outcome Measures

IBM Computer Usability Satisfaction Questionnaires (CSUQ)
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.
COPE Knowledge Acquisition Test (CKAT)
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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
September 7, 2023
Sponsor
VA Office of Research and Development
Collaborators
Medical University of South Carolina, National Center for PTSD
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1. Study Identification

Unique Protocol Identification Number
NCT05812131
Brief Title
COPEWeb Training for Providers
Acronym
COPEWeb
Official Title
Web-Based Provider Training for Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPEWeb)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
April 5, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Medical University of South Carolina, National Center for PTSD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Substance Use Disorders
Keywords
PTSD, substance use disorders, training, providers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Providers will be randomly assigned to COPEWeb online training or in-person COPE training
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPEWEb
Arm Type
Experimental
Arm Description
online COPEWeb training
Arm Title
COPE In person
Arm Type
Active Comparator
Arm Description
COPE training delivered in person
Intervention Type
Behavioral
Intervention Name(s)
COPEWeb online training
Intervention Description
COPE training delivered via online COPEWEb to providers
Intervention Type
Behavioral
Intervention Name(s)
COPE In Person
Intervention Description
COPE training provided in person to providers
Primary Outcome Measure Information:
Title
IBM Computer Usability Satisfaction Questionnaires (CSUQ)
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Title
COPE Knowledge Acquisition Test (CKAT)
Description
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.
Time Frame
Change from baseline to study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sudie E Back, PhD
Phone
(843) 792-9383
Email
Sudie.Back@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey S Sellers
Phone
(843) 789-6703
Ext
206703
Email
Stacey.Sellers@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudie E. Back, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudie E Back, PhD
Phone
843-792-9383
Email
Sudie.Back@va.gov
First Name & Middle Initial & Last Name & Degree
Sudie E. Back, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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