Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05812131
Other study ID # IIR 21-005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date April 5, 2027

Study information

Verified date January 2024
Source VA Office of Research and Development
Contact Sudie E Back, PhD
Phone (843) 792-9383
Email Sudie.Back@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date April 5, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
COPEWeb online training
COPE training delivered via online COPEWEb to providers
COPE In Person
COPE training provided in person to providers

Locations

Country Name City State
United States Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Medical University of South Carolina, National Center for PTSD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 8 weeks
Primary 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. Change from baseline to study completion, an average of 8 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Not yet recruiting NCT04056767 - Changes in Digital Phenotype During PE Therapy
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Completed NCT01955538 - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees. Phase 3
Withdrawn NCT01957371 - Mindful Yoga Therapy for Veterans With PTSD and Pain N/A