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
Brief Pain Inventory, Interference Subscale Score	The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Brief Pain Inventory, Interference Score	The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.	6 months, 12 months
Numeric Rating Score, Pain Intensity	The single average pain intensity rating question from the self-reported, Brief Pain Inventory. Data will be collected through automated IVR calls.	4 month
PEG-3	A Three-Item Scale Assessing Pain Intensity and Interference. Data will be collected through automated IVR calls.	4 month
Depression symptom severity	Depression symptom severity will be assessed using the 8-item Patient Health Questionnaire (PHQ-8) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR.	4 months
Pain Catastrophizing Scale- 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. Data will be collected through an automated IVR	4 months
Sleep Quality	Sleep quality will be measured using the Insomnia Severity Index and will assess subjective sleep quality. Data will be collected through automated IVR calls.	4 months
Pain Self-Efficacy	Self-Efficacy will be assessed using 1-Item of the Pain Self-Efficacy Questionnaire. Data will be collected through automated IVR calls.	4 months
Patient Global Perception of Change	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. Data will be collected through automated IVR calls.	4 months
Pain Satisfaction Questionnaire	Pain satisfaction will be measured using an adapted Pain Satisfaction Questionnaire. This 5-item measure about patient self report of experience of treatment . Data will be collected through automated IVR calls.	4 month
Treatment dose	Number of cognitive behavioral therapy for chronic pain sessions attended for this treatment.	Up to 12 months post baseline

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 27, 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): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; 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