Skip to main content
OpenTrials
Completed

NCT Number: NCT03469505

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines, Jr. VA Hospital, Hines, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COPES

Behavioral

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

CBT-cp

Behavioral

Cognitive Behavioral Therapy for Chronic Pain

Primary outcomes

  1. Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score

    Time frame: 4 months

    The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.

Secondary outcomes

  1. Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score

    Time frame: 6 months

    The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.

  2. Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score

    Time frame: 12 months

    The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.

  3. Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score

    Time frame: 4 month

    The PEG-3 is a three-Item Scale Assessing Pain Intensity and Interference. Data was collected through automated IVR calls with a range from 0-10. Higher scores indicate more pain impact (intensity and interference).

  4. Mean Patient Health Questionnaire (PHQ-8) Score

    Time frame: 4 months

    PHQ-8 is a Depression symptom severity scale will be assessed using the 8-item a widely-used measure with excellent internal consistency and stability.PHQ-8 score range is 0-24; ≥10 indicates clinically significant depressive symptoms. Higher scores indicate more depressive symptomatology.

  5. Mean Pain Catastrophizing Scale (PCS)- 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. Total score range 3-15 with higher scores indicating more catatrophizing.

  6. Mean Insomnia Severity Index (ISI) Score

    Time frame: 4 months

    Sleep quality was measured using the ISI and will assess subjective sleep quality. ISI score range 0-28, higher scores indicate higher sleep difficulty, (15 or above clinical insomnia).

  7. Mean Pain Self-Efficacy Questionnaire (PSEQ) Score

    Time frame: 4 months

    Self-Efficacy will be assessed using 1-Item of the PSEQ.PSEQ score range 0- 10. Higher scores indicate higher pain self-efficacy.

  8. Patient Global Perception of Change (PGIC)

    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 1-7s scale with 1 as "much worse" to "much better" scale. For PGIC (ordinal) data repored is number of participants with at least moderate improvement (score>=5).

  9. Mean Pain Satisfaction Questionnaire Score

    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 . The questions are on a scale from (0=very dissatisfied to 4=very satisfied). Total score range 0-4 with higher scores indicating more satisfaction.

  10. Difference in Treatment Dose

    Time frame: Up to 12 months post baseline

    Number of cognitive behavioral therapy for chronic pain sessions or COPES sessions attended for this treatment. Data presented is the number of sessions completed by expected number of sessions, among participants who initiated treatment.

  11. Mean Numeric Rating Score (NRS), Pain Intensity Score

    Time frame: 4 months

    Average pain intensity NRS rating (over past week) range is 0-10. Higher scores indicate more pain.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: COPES ExTRA

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2018
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.