Clinical trial NCT03469505: Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Official title: Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-03-19
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brief Pain Inventory, Interference Subscale Score
timeFrame: 4 months
Secondary outcomes:
measure: The Brief Pain Inventory, Interference Score
timeFrame: 6 months, 12 months
measure: Numeric Rating Score, Pain Intensity
timeFrame: 4 month
measure: PEG-3
timeFrame: 4 month
measure: Depression symptom severity
timeFrame: 4 months
measure: Pain Catastrophizing Scale- Short Form
timeFrame: 4 months
measure: Sleep Quality
timeFrame: 4 months
measure: Pain Self-Efficacy
timeFrame: 4 months
measure: Patient Global Perception of Change
timeFrame: 4 months
measure: Pain Satisfaction Questionnaire
timeFrame: 4 month
measure: Treatment dose
timeFrame: Up to 12 months post baseline
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Leeds
country: United States
facility: VA Central Western Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Jackson
country: United States
facility: G.V. (Sonny) Montgomery VA Medical Center
state: Mississippi
city: Oklahoma City
country: United States
facility: Oklahoma City VA Health Care System
state: Oklahoma
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Dallas
country: United States
facility: VA North Texas Healthcare System
state: Texas
city: Temple
country: United States
facility: VA Central Texas Healthcare System
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
Study officials:
affiliation: VA Office of Research and Development
name: Alicia Heapy, Phd
role: PRINCIPAL_INVESTIGATOR
References: