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

Pain, Chronic Clinical Trial

— COPES ExTRA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03469505
• Other study ID #: 2000024225
• Secondary ID: 1UG3AT009767-014
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 27, 2019
• Est. completion date: February 20, 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 764
• Est. completion date: February 20, 2025
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Behavioral:
• COPES
Cooperative Pain Education and Self-Management for chronic pain therapy.
• CBT-CP
Cognitive Behavioral Therapy for Chronic Pain

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina
United States	VA North Texas Healthcare System	Dallas	Texas
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	G.V. (Sonny) Montgomery VA Medical Center	Jackson	Mississippi
United States	VA Central Western Massachusetts	Leeds	Massachusetts
United States	Oklahoma City VA Health Care System	Oklahoma City	Oklahoma
United States	VA Puget Sound Healthcare System	Seattle	Washington
United States	VA Central Texas Healthcare System	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory	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.	1 month
Primary	Brief Pain Inventory	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 months
Primary	Brief Pain Inventory	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.	6 months
Primary	Brief Pain Inventory	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.	12 months
Secondary	Current Pain Intensity Rating	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).	1 month
Secondary	Current Pain Intensity Rating	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 months
Secondary	Current Pain Intensity Rating	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).	6 months
Secondary	Current Pain Intensity Rating	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).	12 months
Secondary	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.	1 month
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	Depression symptom severity	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.	1 month
Secondary	Depression symptom severity	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.	3 months
Secondary	Depression symptom severity	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.	6 months
Secondary	Depression symptom severity	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 months
Secondary	Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain	1 month
Secondary	Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain	3 months
Secondary	Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain	6 months
Secondary	Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain	12 months
Secondary	Sleep Quality	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.	1 month
Secondary	Sleep Quality	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.	3 months
Secondary	Sleep Quality	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.	6 months
Secondary	Sleep Quality	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.	12 months
Secondary	Pain Efficacy	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.	1 month
Secondary	Pain Efficacy	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.	3 months
Secondary	Pain Efficacy	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.	6 months
Secondary	Pain Efficacy	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.	12 months
Secondary	Health-Related Quality of Life	We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.	1 month
Secondary	Health-Related Quality of Life	We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.	3 months
Secondary	Health-Related Quality of Life	We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.	6 months
Secondary	Health-Related Quality of Life	We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.	12 months
Secondary	Pain Outcomes	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.	1 month