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

Not Applicable

Active, not recruiting

• Conditions: Pain, Chronic
• Interventions: Behavioral: COPES; Behavioral: CBT-CP

• Registration Number: NCT03469505
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-19
• Study Start: 2019-12-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 764

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.

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Exclusion Criteria

• Patients not fitting criteria for inclusion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
data from veterans using COPES	COPES	Data from veterans using COPES for chronic pain
data from veterans using CBT-CP	CBT-CP	Data from veterans using CBT-CP for chronic pain

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory	12 months	The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated IVR calls.

Secondary Outcome Measures

Name	Time	Method
Depression symptom severity	12 months	Depression symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR.
Sleep Quality	12 months	Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and will assess subjective sleep quality. Data will be collected through automated IVR calls.
Current Pain Intensity Rating	12 months	VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) NRS for current pain be collected at the point of care for every visit as part of the vital signs assessment.This data will be extracted from the electronic health records (EHR).
Pain Efficacy	12 months	Self-Efficacy will be assessed using the 2-Item Short Form of the Pain Self-Efficacy Questionnaire (PSEQ-2). Data will be collected through automated IVR calls.
Patient Global Perception of Change	12 months	The Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 7 point "much worse" to "much better" scale.
Pain Catastrophizing Scale	12 months	The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
Pain Outcomes	1 month	Pain outcomes will be measured using the Patient Outcomes Questionnaire. This 5-item measure shows good internal consistency and significant associations with staff and patient ratings of patient improvement. The data will be collected through automated IVR calls.
Health-Related Quality of Life	12 months	We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.

Trial Locations

Locations (9)

Edward Hines, Jr. VA Hospital; 🇺🇸 Hines, Illinois, United States

G.V. (Sonny) Montgomery VA Medical Center; 🇺🇸 Jackson, Mississippi, United States

VA Central Texas Healthcare System; 🇺🇸 Temple, Texas, United States

VA North Texas Healthcare System; 🇺🇸 Dallas, Texas, United States

VA Central Western Massachusetts; 🇺🇸 Leeds, Massachusetts, United States

VA Ann Arbor Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States

Oklahoma City VA Health Care System; 🇺🇸 Oklahoma City, Oklahoma, United States

VA Puget Sound Healthcare System; 🇺🇸 Seattle, Washington, United States

Ralph H. Johnson VA Medical Center; 🇺🇸 Charleston, South Carolina, United States