NCT05812131

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 and was designated as a first-line treatment in the 2025 APA Clinical Practice Guideline for PTSD. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2025Apr 2027

First Submitted

Initial submission to the registry

March 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

March 13, 2023

Last Update Submit

August 5, 2025

Conditions

Keywords

PTSDsubstance use disorderstrainingproviders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

COPEWEb

EXPERIMENTAL

online COPEWeb training

Behavioral: COPEWeb online training

COPE In person

ACTIVE COMPARATOR

COPE training delivered in person

Behavioral: COPE In Person

Interventions

COPE training delivered via online COPEWEb to providers

COPEWEb
COPE In PersonBEHAVIORAL

COPE training provided in person to providers

COPE In person

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • currently a provider in a behavioral health field (e.g., psychology, psychiatry, counseling)
  • 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

You may not qualify if:

  • received prior training in COPE
  • not a provider in the behavioral health field
  • non-English speaking
  • lack of reliable internet access
  • younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Sudie E. Back, PhD

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudie E Back, PhD

CONTACT

Stacey S Sellers, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: Providers will be randomly assigned to COPEWeb online training or in-person COPE training
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 13, 2023

Study Start

May 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 5, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations