Pain, Chronic
Conditions
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.
Interventions
BEHAVIORALCOPES
Cooperative Pain Education and Self-Management for chronic pain therapy.
BEHAVIORALCBT-CP
Cognitive Behavioral Therapy for Chronic Pain
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory, Interference Subscale Score | 4 months | The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Score, Pain Intensity | 4 month | The single average pain intensity rating question from the self-reported, Brief Pain Inventory. Data will be collected through automated IVR calls. |
| PEG-3 | 4 month | A Three-Item Scale Assessing Pain Intensity and Interference. Data will be collected through automated IVR calls. |
| Depression symptom severity | 4 months | Depression symptom severity will be assessed using the 8-item Patient Health Questionnaire (PHQ-8) a widely-used measure with excellent internal consistency and stability. Data will be collected through an automated IVR. |
| Pain Catastrophizing Scale- Short Form | 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. Data will be collected through an automated IVR |
| The Brief Pain Inventory, Interference Score | 6 months, 12 months | The Brief Pain Inventory Interference Score is patient-reported pain-related interference. Data will be collected through automated IVR calls. |
| Pain Self-Efficacy | 4 months | Self-Efficacy will be assessed using 1-Item of the Pain Self-Efficacy Questionnaire. Data will be collected through automated IVR calls. |
| Patient Global Perception of Change | 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 7 point much worse to much better scale. Data will be collected through automated IVR calls. |
| Pain Satisfaction Questionnaire | 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 . Data will be collected through automated IVR calls. |
| Treatment dose | Up to 12 months post baseline | Number of cognitive behavioral therapy for chronic pain sessions attended for this treatment. |
| Sleep Quality | 4 months | Sleep quality will be measured using the Insomnia Severity Index and will assess subjective sleep quality. Data will be collected through automated IVR calls. |
Countries
United States
Outcome results
None listed