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

Primary Purpose

Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPES
CBT-CP
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Edward Hines, Jr. VA HospitalRecruiting
  • VA Central Western MassachusettsRecruiting
  • VA Ann Arbor Healthcare SystemRecruiting
  • G.V. (Sonny) Montgomery VA Medical CenterRecruiting
  • Oklahoma City VA Health Care SystemRecruiting
  • Ralph H. Johnson VA Medical CenterRecruiting
  • VA North Texas Healthcare SystemRecruiting
  • VA Central Texas Healthcare SystemRecruiting
  • VA Puget Sound Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

data from veterans using COPES

data from veterans using CBT-CP

Arm Description

Data from veterans using COPES for chronic pain

Data from veterans using CBT-CP for chronic pain

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 2, 2018
Last Updated
May 25, 2023
Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03469505
Brief Title
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Acronym
COPES ExTRA
Official Title
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
723 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
data from veterans using COPES
Arm Type
Active Comparator
Arm Description
Data from veterans using COPES for chronic pain
Arm Title
data from veterans using CBT-CP
Arm Type
Active Comparator
Arm Description
Data from veterans using CBT-CP for chronic pain
Intervention Type
Behavioral
Intervention Name(s)
COPES
Intervention Description
Cooperative Pain Education and Self-Management for chronic pain therapy.
Intervention Type
Behavioral
Intervention Name(s)
CBT-CP
Intervention Description
Cognitive Behavioral Therapy for Chronic Pain
Primary Outcome Measure Information:
Title
Brief Pain Inventory
Description
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.
Time Frame
1 month
Title
Brief Pain Inventory
Description
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.
Time Frame
3 months
Title
Brief Pain Inventory
Description
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.
Time Frame
6 months
Title
Brief Pain Inventory
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Current Pain Intensity Rating
Description
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).
Time Frame
1 month
Title
Current Pain Intensity Rating
Description
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).
Time Frame
3 months
Title
Current Pain Intensity Rating
Description
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).
Time Frame
6 months
Title
Current Pain Intensity Rating
Description
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).
Time Frame
12 months
Title
Patient Global Perception of Change
Description
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.
Time Frame
1 month
Title
Patient Global Perception of Change
Description
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.
Time Frame
3 months
Title
Patient Global Perception of Change
Description
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.
Time Frame
6 months
Title
Patient Global Perception of Change
Description
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.
Time Frame
12 months
Title
Depression symptom severity
Description
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.
Time Frame
1 month
Title
Depression symptom severity
Description
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.
Time Frame
3 months
Title
Depression symptom severity
Description
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.
Time Frame
6 months
Title
Depression symptom severity
Description
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.
Time Frame
12 months
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
Time Frame
1 month
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
Time Frame
3 months
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
Time Frame
6 months
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) a 13-item self-report scale that examines thoughts and feelings people may experience when they are in pain
Time Frame
12 months
Title
Sleep Quality
Description
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.
Time Frame
1 month
Title
Sleep Quality
Description
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.
Time Frame
3 months
Title
Sleep Quality
Description
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.
Time Frame
6 months
Title
Sleep Quality
Description
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.
Time Frame
12 months
Title
Pain Efficacy
Description
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.
Time Frame
1 month
Title
Pain Efficacy
Description
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.
Time Frame
3 months
Title
Pain Efficacy
Description
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.
Time Frame
6 months
Title
Pain Efficacy
Description
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.
Time Frame
12 months
Title
Health-Related Quality of Life
Description
We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
Time Frame
1 month
Title
Health-Related Quality of Life
Description
We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
Time Frame
3 months
Title
Health-Related Quality of Life
Description
We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
Time Frame
6 months
Title
Health-Related Quality of Life
Description
We will use the Veterans SF-12 to assess health-related quality of life. Data will be collected through automated IVR calls.
Time Frame
12 months
Title
Pain Outcomes
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn LaChappelle, MPH
Phone
203-690-8082
Email
kathryn.lachappelle@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Heapy, Phd
Organizational Affiliation
VA Office of Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Goldstein, PhD
Facility Name
VA Central Western Massachusetts
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Mattocks, PhD
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Krein, PhD
Facility Name
G.V. (Sonny) Montgomery VA Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley King-Profit, PhD
Facility Name
Oklahoma City VA Health Care System
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Yamamoto, PhD
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Layne Goble, PhD
Facility Name
VA North Texas Healthcare System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Una Makris, PhD
Facility Name
VA Central Texas Healthcare System
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Mignona, PhD
Facility Name
VA Puget Sound Healthcare System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Chen, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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