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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment COPEWeb online training for PTSD and Substance Use Disorder?

Research shows that integrated treatments like COPE, which combine exposure therapy for PTSD and cognitive behavioral techniques for substance use disorders, are promising and feasible. These treatments have been effective in reducing symptoms of both PTSD and substance use disorders, especially in veterans and individuals with co-occurring conditions. ^{1 2 3 4 5}

Is COPEWeb Training for PTSD and Substance Use Disorder safe for humans?

Research on similar treatments, like COPE and Seeking Safety, shows they are generally safe for people with PTSD and substance use disorders, with minimal adverse effects reported. ^{2 5 6 7 8}

How is the COPEWeb online training treatment for PTSD and Substance Use Disorder different from other treatments?

COPEWeb is unique because it combines exposure-based techniques, which are effective for PTSD, with cognitive behavioral techniques for substance use disorders, offering an integrated approach to treat both conditions simultaneously. ^{1 5 8 9 10}

Research Team

Sudie E. Back, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

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

I do not speak English.

Not a provider in the behavioral health field in the VA

Lack of reliable internet access

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Use of Exposure-Based Treatment Among Individuals With PTSD and Co-occurring Substance Use Disorders: Clinical Considerations. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE): A Pilot Study in Alcohol-dependent Women. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The influence of traumatic brain injury on treatment outcomes of Concurrent Treatment for PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) in veterans. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Exposure therapy in the treatment of PTSD among cocaine-dependent individuals: description of procedures. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The role of posttraumatic guilt and anger in integrated treatment for PTSD and co-occurring substance use disorders among primarily male veterans. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Seeking Safety plus Exposure Therapy: an outcome study on dual diagnosis men. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Concurrent Treatment with Prolonged Exposure for Co-Occurring Full or Subthreshold Posttraumatic Stress Disorder and Substance Use Disorders: A Randomized Clinical Trial. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A Seeking Safety Mobile App for Recovery from PTSD and Substance Use Disorder: Results of a Randomized Controlled Trial. [2023]