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
Yale University
National Center for Complementary and Integrative Health (NCCIH)
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 |
|---|---|---|
| Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score | 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. |
| Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score | 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). |
| Mean Patient Health Questionnaire (PHQ-8) Score | 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. |
| Mean Pain Catastrophizing Scale (PCS)- 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. Total score range 3-15 with higher scores indicating more catatrophizing. |
| Mean Insomnia Severity Index (ISI) Score | 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). |
| Mean Pain Self-Efficacy Questionnaire (PSEQ) Score | 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. |
| Patient Global Perception of Change (PGIC) | 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). |
| Mean Pain Satisfaction Questionnaire Score | 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. |
| Difference in Treatment Dose | 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. |
| Mean Numeric Rating Score (NRS), Pain Intensity Score | 4 months | Average pain intensity NRS rating (over past week) range is 0-10. Higher scores indicate more pain. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlicia Heapy, Phd
VA Office of Research and Development
Participant flow
Pre-assignment details
Of the 384 participants randomized to COPES arm, 362 initiated treatment. Of the 380 participants randomized to CBT-CP arm, 249 initiated treatment. All randomized participants were asked to complete all follow up.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 12.3 |
| Brief Pain Inventory-Interference (BPI-I) subscale | 6.8 pain interference score STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 656 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insomnia Severity Index (ISI) | 20.5 sleep hygiene symptom score STANDARD_DEVIATION 5.8 |
| Numeric Rating Scale (NRS), Pain Intensity | 6.7 pain score STANDARD_DEVIATION 1.6 |
| Pain Catastrophizing Scale, Short Form (PCS-SF) | 11.1 Catastrophizing thinking score STANDARD_DEVIATION 3 |
| Pain, Enjoyment, General activity scale(PEG)- 3 item | 6.9 PEG-3 score STANDARD_DEVIATION 1.6 |
| Pain Self-Efficacy Questionnaire, Short Form (PSEQ-SF) | 4.2 pain self-efficacy score STANDARD_DEVIATION 2.6 |
| Patient Health Questionnaire-(PHQ) 8 item | 16.3 Depression symptom score STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 150 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 399 Participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 235 Participants |
| Study Site Site 1 | 38 Participants |
| Study Site Site 2 | 34 Participants |
| Study Site Site 3 | 49 Participants |
| Study Site Site 4 | 391 Participants |
| Study Site Site 5 | 49 Participants |
| Study Site Site 6 | 20 Participants |
| Study Site Site 7 | 21 Participants |
| Study Site Site 8 | 57 Participants |
| Study Site Site 9 | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 384 | 3 / 380 |
| other Total, other adverse events | 0 / 384 | 0 / 380 |
| serious Total, serious adverse events | 31 / 384 | 49 / 380 |
Outcome results
None listed