Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)

Yale University

Status: Completed

Conditions: Pain, Chronic

Treatments: Behavioral: COPES; Behavioral: CBT-CP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03469505

1UG3AT009767-01 (U.S. NIH Grant/Contract)

2000024225

4UH3AT009767-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)

Full 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, presumably due to the ease of in-home treatment attendance relative to in-person treatment.

Enrollment: 764 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients not fitting criteria for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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764 participants in 2 patient groups

data from veterans using COPES

Active Comparator group

Description:

Data from veterans using COPES for chronic pain

Treatment:

Behavioral: COPES

data from veterans using CBT-CP

Active Comparator group

Description:

Data from veterans using CBT-CP for chronic pain

Treatment:

Behavioral: CBT-CP