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

• ClinicalTrials.gov Identifier: NCT03469505
• Recruitment Status: Recruiting
• First Posted: March 19, 2018
• Last Update Posted: May 26, 2023
• Sponsor: Yale University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain, Chronic	Behavioral: COPES; Behavioral: CBT-CP	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 723 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
• Actual Study Start Date: December 27, 2019
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Brief Pain Inventory [ Time Frame: 1 month ]
   The Total Brief Pain Inventory Score is a composite of patient-reported pain intensity and pain-related interference. Data will be collected through automated Interactive Voice Response (IVR) calls.
2. Brief Pain Inventory [ Time Frame: 3 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.
3. Brief Pain Inventory [ Time Frame: 6 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.
4. Brief Pain Inventory [ Time Frame: 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 :

1. Current Pain Intensity Rating [ Time Frame: 1 month ]
   VHA care guidelines specify that the 11-point (no pain) to (worst pain imaginable) Numeric Rating Scale (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).
2. Current Pain Intensity Rating [ Time Frame: 3 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).
3. Current Pain Intensity Rating [ Time Frame: 6 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).
4. Current Pain Intensity Rating [ Time Frame: 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).
5. Patient Global Perception of Change [ Time Frame: 1 month ]
   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.
6. Patient Global Perception of Change [ Time Frame: 3 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.
7. Patient Global Perception of Change [ Time Frame: 6 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.
8. Patient Global Perception of Change [ Time Frame: 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.
9. Depression symptom severity [ Time Frame: 1 month ]
   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.
10. Depression symptom severity [ Time Frame: 3 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.
11. Depression symptom severity [ Time Frame: 6 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.
12. Depression symptom severity [ Time Frame: 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.
13. Pain Catastrophizing Scale [ Time Frame: 1 month ]
    The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
14. Pain Catastrophizing Scale [ Time Frame: 3 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
15. Pain Catastrophizing Scale [ Time Frame: 6 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
16. Pain Catastrophizing Scale [ Time Frame: 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
17. Sleep Quality [ Time Frame: 1 month ]
    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.
18. Sleep Quality [ Time Frame: 3 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.
19. Sleep Quality [ Time Frame: 6 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.
20. Sleep Quality [ Time Frame: 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.
21. Pain Efficacy [ Time Frame: 1 month ]
    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.
22. Pain Efficacy [ Time Frame: 3 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.
23. Pain Efficacy [ Time Frame: 6 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.
24. Pain Efficacy [ Time Frame: 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.
25. Health-Related Quality of Life [ Time Frame: 1 month ]
    We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
26. Health-Related Quality of Life [ Time Frame: 3 months ]
    We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
27. Health-Related Quality of Life [ Time Frame: 6 months ]
    We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
28. Health-Related Quality of Life [ Time Frame: 12 months ]
    We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
29. Pain Outcomes [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Kathryn LaChappelle, MPH; 203-690-8082; kathryn.lachappelle@va.gov

Locations

United States, Illinois

Edward Hines, Jr. VA Hospital; Recruiting

Hines, Illinois, United States, 60141

Contact: Daniel Goldstein, PhD

United States, Massachusetts

VA Central Western Massachusetts; Recruiting

Leeds, Massachusetts, United States, 01053

Contact: Kristin Mattocks, PhD

United States, Michigan

VA Ann Arbor Healthcare System; Recruiting

Ann Arbor, Michigan, United States, 48105

Contact: Sarah Krein, PhD

United States, Mississippi

G.V. (Sonny) Montgomery VA Medical Center; Recruiting

Jackson, Mississippi, United States, 39216

Contact: Ashley King-Profit, PhD

United States, Oklahoma

Oklahoma City VA Health Care System; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contact: Laura Yamamoto, PhD

United States, South Carolina

Ralph H. Johnson VA Medical Center; Recruiting

Charleston, South Carolina, United States, 29401

Contact: Layne Goble, PhD

United States, Texas

VA North Texas Healthcare System; Recruiting

Dallas, Texas, United States, 75216

Contact: Una Makris, PhD

VA Central Texas Healthcare System; Recruiting

Temple, Texas, United States, 76504

Contact: Joseph Mignona, PhD

United States, Washington

VA Puget Sound Healthcare System; Recruiting

Seattle, Washington, United States, 98108

Contact: Jessica Chen, PhD

Sponsors and Collaborators

Yale University

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Alicia Heapy, Phd; VA Office of Research and Development

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03469505
• Other Study ID Numbers: 2000024225; 1UG3AT009767-01 ( U.S. NIH Grant/Contract ); 4UH3AT009767-03 ( U.S. NIH Grant/Contract )
• First Posted: March 19, 2018
• Last Update Posted: May 26, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations