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

May 19, 2025 updated by: Yale University
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
764

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory, Interference Subscale Score
Time Frame: 4 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Brief Pain Inventory, Interference Score
Time Frame: 6 months, 12 months
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
Time Frame: 4 month
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
Time Frame: 4 month
A Three-Item Scale Assessing Pain Intensity and Interference. Data will be collected through automated IVR calls.
4 month
Depression symptom severity
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 months
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
Time Frame: 4 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. Data will be collected through automated IVR calls.
4 months
Pain Satisfaction Questionnaire
Time Frame: 4 month
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
Time Frame: Up to 12 months post baseline
Number of cognitive behavioral therapy for chronic pain sessions attended for this treatment.
Up to 12 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alicia Heapy, Phd, VA Office of Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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