Pain, ChronicCOPES ExTRANCT03469505
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
A study testing COPES and CBT-CP in people with Pain, Chronic, run by Yale University at 9 sites in United States.
Trial summary
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- COPES and CBT-CP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Dec 2019to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients not fitting criteria for inclusion.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
VA North Texas Healthcare System
Dallas, Texas, 75216
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141
G.V. (Sonny) Montgomery VA Medical Center
Jackson, Mississippi, 39216
VA Central Western Massachusetts
Leeds, Massachusetts, 01053
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, 73104
VA Puget Sound Healthcare System
Seattle, Washington, 98108
VA Central Texas Healthcare System
Temple, Texas, 76504
About this study
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)
Read the 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.
- Conditions
- Pain, Chronic
- Being tested
- COPES, CBT-CP
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPESBehavioural
Cooperative Pain Education and Self-Management for chronic pain therapy.
CBT-CPBehavioural
Cognitive Behavioral Therapy for Chronic Pain
| Study group | Role | What they receive |
|---|---|---|
| data from veterans using COPES | Active comparator | Data from veterans using COPES for chronic pain Receives: Behavioral: COPES |
| data from veterans using CBT-CP | Active comparator | Data from veterans using CBT-CP for chronic pain Receives: Behavioral: CBT-CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Measured: 4 months
Secondary outcomes (11)
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Measured: 6 months
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Measured: 12 months
Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score
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).
Measured: 4 month
Mean Patient Health Questionnaire (PHQ-8) Score
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.
Measured: 4 months
Mean Pain Catastrophizing Scale (PCS)- Short Form
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.
Measured: 4 months
Mean Insomnia Severity Index (ISI) Score
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).
Measured: 4 months
Mean Pain Self-Efficacy Questionnaire (PSEQ) Score
Self-Efficacy will be assessed using 1-Item of the PSEQ.PSEQ score range 0- 10. Higher scores indicate higher pain self-efficacy.
Measured: 4 months
Patient Global Perception of Change (PGIC)
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).
Measured: 4 months
Mean Pain Satisfaction Questionnaire Score
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.
Measured: 4 month
Difference in Treatment Dose
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.
Measured: Up to 12 months post baseline
Mean Numeric Rating Score (NRS), Pain Intensity Score
Average pain intensity NRS rating (over past week) range is 0-10. Higher scores indicate more pain.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start20 Dec 2019
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Alicia Heapy, Phd, Principal investigator, VA Office of Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469505
- Sponsor's protocol ID
- 2000024225
- Other IDs
- 1UG3AT009767-01, 4UH3AT009767-03
- Acronym
- COPES ExTRA
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2018
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heapy AA, Driscoll MA, Edmond S, LaChappelle KM, Buta E, Halat A, Krein SL, Martino S, DeBar L, Murphy JL, Mattocks K, Coleman BC, Ruser C, Piette JD, MacLean RR, Ankawi B, Cervone D, Wagner TH, Higgins DM. Self-Directed vs Clinician-Delivered Cognitive Behavioral Therapy for Chronic Pain: A Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):400-412. doi: 10.1001/jama.2026.7861.
PubMed 42340733
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
- ClinicalTrials.gov ID
- NCT03469505
- Acronym / sponsor ID
- COPES ExTRA / 2000024225
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| data from veterans using COPES | Active comparator | Behavioral: COPESData from veterans using COPES for chronic pain |
| data from veterans using CBT-CP | Active comparator | Behavioral: CBT-CPData from veterans using CBT-CP for chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not fitting criteria for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPESCooperative Pain Education and Self-Management for chronic pain therapy. | Behavioural | data from veterans using COPES |
| CBT-CPCognitive Behavioral Therapy for Chronic Pain | Behavioural | data from veterans using CBT-CP |
Primary outcome
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.
11 secondary outcomes
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
Time frame: 6 months
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
Time frame: 12 months
Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score
Time frame: 4 month
Mean Patient Health Questionnaire (PHQ-8) Score
Time frame: 4 months
Mean Pain Catastrophizing Scale (PCS)- Short Form
Time frame: 4 months
Mean Insomnia Severity Index (ISI) Score
Time frame: 4 months
Mean Pain Self-Efficacy Questionnaire (PSEQ) Score
Time frame: 4 months
Patient Global Perception of Change (PGIC)
Time frame: 4 months
Mean Pain Satisfaction Questionnaire Score
Time frame: 4 month
Difference in Treatment Dose
Time frame: Up to 12 months post baseline
Mean Numeric Rating Score (NRS), Pain Intensity Score
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42340733Heapy AA, Driscoll MA, Edmond S, LaChappelle KM, Buta E, Halat A, Krein SL, Martino S, DeBar L, Murphy JL, Mattocks K, Coleman BC, Ruser C, Piette JD, MacLean RR, Ankawi B, Cervone D, Wagner TH, Higgins DM. Self-Directed vs Clinician-Delivered Cognitive Behavioral Therapy for Chronic Pain: A Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):400-412. doi: 10.1001/jama.2026.7861.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Heapy, Phd principal investigator
VA Office of Research and Development
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPES and CBT-CP in people with Pain, Chronic, run by Yale University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.