Status:
COMPLETED
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Pain, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)
Detailed Description
Our prior efficacy trial found that COPES was not inferior to in-person CBT-CP and that participants attended, on average, a little over two more treatment weeks in COPES than in-person treatment, pre...
Eligibility Criteria
Inclusion
- Patients with chronic musculoskeletal pain receiving care in VHA.
- A pain-related musculoskeletal diagnosis indicated by an EHR identified ICD-9 or -10 code.
- The presence of chronic pain of at least moderate severity with EHR NRS pain scores ≥ 4 in three separate months for a period of 12 months.
- Absence of mental illness serious enough to have resulted in an inpatient psychiatric hospitalization in the prior 3 months excluding detoxification of alcohol or drugs.
- Absence of malignant cancer diagnosis or receipt of hospice or end-of-life palliative care.
- Ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block and absence of diabetic foot ulcers at the time of the enrollment.
- Absence of significant cognitive impairment as identified by a dementia-related diagnosis.
- Availability of a touch-tone land-line or cellular telephone and no vision or hearing deficits that would impair participation verified by patient report at the time of the enrollment call.
Exclusion
- Patients not fitting criteria for inclusion.
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
764 Patients enrolled
Trial Details
Trial ID
NCT03469505
Start Date
December 27 2019
End Date
February 20 2025
Last Update
May 21 2025
Active Locations (9)
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1
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141
2
VA Central Western Massachusetts
Leeds, Massachusetts, United States, 01053
3
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
4
G.V. (Sonny) Montgomery VA Medical Center
Jackson, Mississippi, United States, 39216