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

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

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Behavioral: COPES; Behavioral: 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 Type: Interventional
• Enrollment (Actual): 764
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141
      • Edward Hines, Jr. VA Hospital
  • Massachusetts
    • Leeds, Massachusetts, United States, 01053
      • VA Central Western Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • G.V. (Sonny) Montgomery VA Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma City VA Health Care System
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VA Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Healthcare System
    • Temple, Texas, United States, 76504
      • VA Central Texas Healthcare System
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: data from veterans using COPES; Data from veterans using COPES for chronic pain	Behavioral: COPES; Cooperative Pain Education and Self-Management for chronic pain therapy.
Active Comparator: data from veterans using CBT-CP; Data from veterans using CBT-CP for chronic pain	Behavioral: CBT-CP; Cognitive Behavioral Therapy for Chronic Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score	The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score	The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.	6 months
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score	The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.	12 months
Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score	The PEG-3 is a three-Item Scale Assessing Pain Intensity and Interference. Data was collected through automated IVR calls with a range from 0-10. Higher scores indicate more pain impact (intensity and interference).	4 month
Mean Patient Health Questionnaire (PHQ-8) Score	PHQ-8 is a Depression symptom severity scale will be assessed using the 8-item a widely-used measure with excellent internal consistency and stability.PHQ-8 score range is 0-24; ≥10 indicates clinically significant depressive symptoms. Higher scores indicate more depressive symptomatology.	4 months
Mean Pain Catastrophizing Scale (PCS)- Short Form	The Pain Catastrophizing Scale (PCS)-Short Form is a validated, 3-item self-report scale that examines thoughts and feelings people may experience when they are in pain. Total score range 3-15 with higher scores indicating more catatrophizing.	4 months
Mean Insomnia Severity Index (ISI) Score	Sleep quality was measured using the ISI and will assess subjective sleep quality. ISI score range 0-28, higher scores indicate higher sleep difficulty, (15 or above clinical insomnia).	4 months
Mean Pain Self-Efficacy Questionnaire (PSEQ) Score	Self-Efficacy will be assessed using 1-Item of the PSEQ.PSEQ score range 0- 10. Higher scores indicate higher pain self-efficacy.	4 months
Patient Global Perception of Change (PGIC)	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 1-7s scale with 1 as "much worse" to "much better" scale. For PGIC (ordinal) data repored is number of participants with at least moderate improvement (score>=5).	4 months
Mean Pain Satisfaction Questionnaire Score	Pain satisfaction will be measured using an adapted Pain Satisfaction Questionnaire. This 5-item measure about patient self report of experience of treatment . The questions are on a scale from (0=very dissatisfied to 4=very satisfied). Total score range 0-4 with higher scores indicating more satisfaction.	4 month
Difference in Treatment Dose	Number of cognitive behavioral therapy for chronic pain sessions or COPES sessions attended for this treatment. Data presented is the number of sessions completed by expected number of sessions, among participants who initiated treatment.	Up to 12 months post baseline
Mean Numeric Rating Score (NRS), Pain Intensity Score	Average pain intensity NRS rating (over past week) range is 0-10. Higher scores indicate more pain.	4 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Alicia Heapy, Phd, VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: 2000024225; 1UG3AT009767-01 (U.S. NIH Grant/Contract); 4UH3AT009767-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No