COPEWeb Training for PTSD and Substance Use Disorder

(COPEWeb Trial)

Overseen By Stacey S Sellers, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-VA provider, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

248 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for Veterans with PTSD (post-traumatic stress disorder) and substance use disorders by training providers through a new online program called COPEWeb. The goal is to equip behavioral health professionals with effective tools to deliver better care to patients facing these challenging conditions. Participants will receive training either online or in person, based on their group assignment. The trial seeks behavioral health providers who have not received formal COPE training and can reliably access the internet.

As an unphased trial, this study offers providers a unique opportunity to enhance their skills and improve patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this web-based training program is safe for providers?

Research shows that the COPE program is generally safe for people with PTSD (post-traumatic stress disorder) and SUD (substance use disorder). Studies with patients reported no serious side effects, such as increased suicidal thoughts or problems with alcohol. This indicates that most people handle the COPE program well. COPEWeb, a new online version of this program, currently lacks specific safety data. However, the COPE program's strong safety record suggests that COPEWeb should also be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPEWeb training for PTSD and Substance Use Disorder because it offers a flexible, online approach that could make treatment more accessible. Unlike traditional in-person therapy, which requires scheduling and traveling to appointments, COPEWeb allows participants to receive support from the comfort of their own homes. This could be especially beneficial for individuals with mobility issues or those living in remote areas. Additionally, the online format may help reduce the stigma associated with seeking help, encouraging more people to engage in treatment.

What evidence suggests that COPEWeb online training is effective for PTSD and substance use disorder?

Research has shown that COPEWeb training effectively treats both PTSD (post-traumatic stress disorder) and substance use disorders. Studies have found that the COPE program uses exposure therapy to help individuals work through trauma and combines it with cognitive behavioral techniques to address substance use. This combination ranks as a top method for treating these conditions together. This trial will compare COPEWeb, the online version of this program, with in-person COPE training. Early results suggest that COPEWeb could enable more providers to offer this effective treatment to a broader audience. Its recognition as a primary treatment in the 2025 APA Clinical Practice Guideline for PTSD supports this approach. ^{1 2 3 5 6}

Who Is on the Research Team?

Sudie E. Back, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for VA behavioral health providers over 18 years old who speak English and have reliable internet access. They must be willing to attend a 2-day COPE training, either in-person or virtual, and engage in patient assessments post-training. Providers with prior formal COPE therapy training are excluded.

Inclusion Criteria

English speaking

Able to consistently obtain reliable internet access

I am willing to attend a 2-day COPE training, either in-person or virtually.

Exclusion Criteria

Not a provider in the behavioral health field in the VA

Lack of reliable internet access

Received prior training in COPE

Timeline for a Trial Participant

Content Development

Development of the web-based training protocol and innovative delivery aid system

Not specified

Alpha-testing

Initial testing phase to refine COPEWeb content and functionality

Not specified

Beta-testing

Further testing phase to finalize COPEWeb before comparison with in-person training

Not specified

Comparison Study

Comparison of COPEWeb to in-person training among clinicians

8 weeks

Follow-up

Ongoing assessment of provider satisfaction, knowledge, and behavior

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COPEWeb online training

Trial Overview The study is testing a new web-based training program (COPEWeb) against the traditional in-person COPE training method to improve PTSD and SUD treatment among military Veterans by enhancing provider skills.

How Is the Trial Designed?

Group I: COPEWEb Experimental Treatment 1 Intervention

online COPEWeb training

Group II: COPE In person Active Control 1 Intervention

COPE training delivered in person

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

National Center for PTSD

Collaborator

Trials

13

Recruited

1,200+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

A pilot study involving 18 veterans showed that the Seeking Safety treatment, a cognitive-behavioral approach for those with both substance use disorders and PTSD, led to significant symptom reduction after 14 months of clinician training.

The treatment was well-received by clinicians, indicating its acceptability in a VA setting, although there are challenges to making it a standard part of routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and feasibility of a cognitive-behavioral treatment for substance use disorders and posttraumatic stress disorder in the Veterans Administration. Cook, JM., Walser, RD., Kane, V., et al.[2022]

In a study involving 353 women in substance abuse treatment, the integrated PTSD treatment (Seeking Safety) did not result in significantly more adverse events compared to a non-trauma-focused intervention (Women's Health Education), indicating that it is safe to implement PTSD treatment in these settings.

Both interventions had low rates of adverse events (9.6% for Seeking Safety and 7.2% for Women's Health Education), suggesting that addressing PTSD in substance abuse programs does not worsen psychiatric or substance use symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Killeen, T., Hien, D., Campbell, A., et al.[2021]

The Seeking Safety (SS) mobile app significantly reduced substance use and trauma symptoms in outpatients with PTSD and substance use disorder, outperforming a control app in a study involving 116 participants over 12 weeks.

This study is important as it demonstrates that mobile apps can effectively deliver mental health interventions, especially since many apps show limited positive outcomes in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Seeking Safety Mobile App for Recovery from PTSD and Substance Use Disorder: Results of a Randomized Controlled Trial. Najavits, LM., Cha, E., Demce, MG., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/L2-n6mYuhEi_2uh17sfkbg/project-details/10950284

Project Details - NIH RePORTER Web-Based Provider Training for Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPEWeb). Project Number5I01HX003483-02.

2. withpower.com withpower.com/trial/phase-substance-related-disorders-7-2023-dcb6a

COPEWeb Training for PTSD and Substance Use Disorder COPEWeb is unique because it combines exposure-based techniques, which are effective for PTSD, with cognitive behavioral techniques for substance use disorders, ...

3. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT05812131

Anxiety & Depression Association of America PTSD and SUD frequently co-occur and are associated with poorer treatment outcomes. The investigators' team developed a trauma-focused ...

4. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1635224.pdf

Treatment of comorbid posttraumatic stress disorder and ... Posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) co- occur at high rates, with research showing that up to nearly 60% of ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836418

Advancing Integrated Treatment for Posttraumatic Stress ... The research literature on the treatment of co-occurring posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) has expanded.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223130/

Concurrent Treatment of PTSD and Substance Use ... ... safety and feasibility. Our data support the safety of COPE in women with comorbid PTSD and AD, as no adverse events (ie, increased suicidality or alcohol ...