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

NCT ID: NCT03469505

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2025-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

data from veterans using COPES

Data from veterans using COPES for chronic pain

Group Type ACTIVE_COMPARATOR

COPES

Intervention Type BEHAVIORAL

Cooperative Pain Education and Self-Management for chronic pain therapy.

data from veterans using CBT-CP

Data from veterans using CBT-CP for chronic pain

Group Type ACTIVE_COMPARATOR

CBT-CP

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Chronic Pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

COPES

Cooperative Pain Education and Self-Management for chronic pain therapy.

Intervention Type BEHAVIORAL

CBT-CP

Cognitive Behavioral Therapy for Chronic Pain

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alicia Heapy, Phd

Role: PRINCIPAL_INVESTIGATOR

VA Office of Research and Development

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edward Hines, Jr. VA Hospital

Hines, Illinois, United States

Site Status

VA Central Western Massachusetts

Leeds, Massachusetts, United States

Site Status

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status

G.V. (Sonny) Montgomery VA Medical Center

Jackson, Mississippi, United States

Site Status

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, United States

Site Status

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status

VA North Texas Healthcare System

Dallas, Texas, United States

Site Status

VA Central Texas Healthcare System

Temple, Texas, United States

Site Status

VA Puget Sound Healthcare System

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1UG3AT009767-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4UH3AT009767-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000024225

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Empowered Relief for Youth
NCT05998369 COMPLETED NA