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

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

Detailed Description
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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.

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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Behavioral: COPES
* Behavioral: CBT-CP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |