NCT03469505
Completed
Not Applicable
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
ConditionsPain, Chronic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Chronic
- Sponsor
- Yale University
- Enrollment
- 764
- Locations
- 9
- Primary Endpoint
- Brief Pain Inventory, Interference Subscale Score
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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, presumably due to the ease of in-home treatment attendance relative to in-person treatment.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Brief Pain Inventory, Interference Subscale Score
Time Frame: 4 months
The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.
Secondary Outcomes
- The Brief Pain Inventory, Interference Score(6 months, 12 months)
- Numeric Rating Score, Pain Intensity(4 month)
- PEG-3(4 month)
- Depression symptom severity(4 months)
- Pain Catastrophizing Scale- Short Form(4 months)
- Sleep Quality(4 months)
- Pain Satisfaction Questionnaire(4 month)
- Treatment dose(Up to 12 months post baseline)
- Pain Self-Efficacy(4 months)
- Patient Global Perception of Change(4 months)
Study Sites (9)
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