NCT03469505

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
764

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 27, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5.2 years

First QC Date

February 2, 2018

Last Update Submit

May 19, 2025

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory, Interference Subscale Score

    The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls.

    4 months

Secondary Outcomes (10)

  • The Brief Pain Inventory, Interference Score

    6 months, 12 months

  • Numeric Rating Score, Pain Intensity

    4 month

  • PEG-3

    4 month

  • Depression symptom severity

    4 months

  • Pain Catastrophizing Scale- Short Form

    4 months

  • +5 more secondary outcomes

Study Arms (2)

data from veterans using COPES

ACTIVE COMPARATOR

Data from veterans using COPES for chronic pain

Behavioral: COPES

data from veterans using CBT-CP

ACTIVE COMPARATOR

Data from veterans using CBT-CP for chronic pain

Behavioral: CBT-CP

Interventions

COPESBEHAVIORAL

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

data from veterans using COPES
CBT-CPBEHAVIORAL

Cognitive Behavioral Therapy for Chronic Pain

data from veterans using CBT-CP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

VA Central Western Massachusetts

Leeds, Massachusetts, 01053, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

G.V. (Sonny) Montgomery VA Medical Center

Jackson, Mississippi, 39216, United States

Location

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

VA Central Texas Healthcare System

Temple, Texas, 76504, United States

Location

VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alicia Heapy, Phd

    VA Office of Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

March 19, 2018

Study Start

December 27, 2019

Primary Completion

February 20, 2025

Study Completion

February 20, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

US(9)