Chronic Pain
Conditions
Keywords
nonpharmacologic treatment, cognitive behavioral therapy, telehealth
Brief summary
The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, health coach-led, virtual sessions (telephone and/or video conference).
Detailed description
Specific Aims Aim #1: Determine the effectiveness of an online, CBT-based pain management program and virtual coach-led (telephonic/video) CBT-CP on achieving clinically meaningful improvements in patients' pain severity (pain intensity + pain-related interference) relative to those receiving usual care at 3 months. 1a. Examine the impact of the active interventions on secondary pain outcomes and related quality of life outcomes (social role functioning, physical functioning, and patient global impression of change); as well as exploratory outcomes, which include long-term opioid use; comorbid symptomology (depression, anxiety, and sleep disturbance); and high impact chronic pain and graded chronic pain. 1b. Conduct subgroup analyses to determine the impact of the active interventions on specific populations and explore for potential heterogeneity of treatment effects by sex; rural/medically underserved residency; multiple pain conditions; mental health mood disorders; and negative social determinants of health. 1c. Examine the role of theory-based mediators, pain catastrophizing, pain-related self-efficacy, and perceived support, on pain-severity. Aim #2: Assess the cost and incremental cost-effectiveness of the online and virtual coach-led CBT-CP interventions compared to each other and usual care. Aim #3: Conduct a qualitative evaluation to understand: 1) patient experiences of the interventions, including how they relate to treatment response, variability by site, and rural/medically underserved residency status; and 2) health system issues, including adaptations and contextual factors at the site and external levels, barriers and facilitators to intervention success and potential for adoption, sustainability and dissemination.
Interventions
BEHAVIORALOnline CBT-CP based program
Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills
BEHAVIORALVirtual health coach-led CBT-CP based program
Live, health coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills
Sponsors
Kaiser Permanente
Essentia Health
Georgia State University
Duke University
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary and secondary outcome assessors will be masked to treatment assignment. It is not feasible for participants to be masked to treatment arm assignment due to the type of intervention. The PI and select Co-Investigators and study staff who are involved in the oversight and delivery of the interventions will also be aware of treatment assignment.
Intervention model description
The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Electronic Health Record-based inclusion criteria: * Active/enrolled in one of the 4 participating integrated health care systems at the time of query and for the prior 360 days * Age 18 years or older (based on date of birth documented in EHR) * English speaking or do not need interpreter services * Have at least one \[at Essentia\] or at least two which are \>60 days apart \[at KP sites\] outpatient pain-related health care encounter with nonmalignant musculoskeletal pain diagnoses \[as determined by ICD10 codes for any of the following: back-neck-, limb/extremity-, joint-pain, arthritic disorders, fibromyalgia, headache, orofacial/temporomandibular pain, or musculoskeletal pain\] within the past 360 days * Do not have an encounter for surgery related to common musculoskeletal pain conditions (e.g., joint replacement, spinal fusion, carpal tunnel release surgery) \[as determined by CPT and/or ICD-10 codes\] within the past 60 days * Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer \[as determined by ICD-10 codes\] within past 60 days * Do not have ICD-10 code(s), Current Procedural Terminology (CPT) code(s) or department/provider encounters indicating receipt of hospice or other palliative care within the past 360 days * Do not have ICD-10 codes indicating severe cognitive impairment precluding participation in a behavioral/ lifestyle change program * Note: At the KPWA site only, one additional EHR-based exclusion criterion will be applied, which is: Do not have ICD-10 codes indicating opioid use disorder (OUD). This criterion is being applied because there is another HEAL study being conducted at KPWA that focuses on treating individuals with pain and OUD specifically.\] Patient-reported inclusion criteria: * Have high-impact chronic pain (as indicated by self-report of having pain on most or every day in past 3 months and pain limiting life or work activities on most or every day in past 3 months) * Have persistent pain (as indicated by self-report Pain, Enjoyment of Life and General Activity (PEG) score of ≥ 12) * Be able to participate in either of the active interventions (i.e., have internet and phone access required for accessing treatments)
Exclusion criteria
(patient-reported): * Have received CBT for pain or pain-related psychoeducation or behavioral skills training within in the past 6 months (in-person, by phone or videoconference, or online) * Currently receiving or will be starting CBT for pain or pain-related psychoeducation or behavioral skills training in the next month (in-person, by phone or videoconference, or online) * Currently receiving or will be starting inpatient or intensive outpatient services for substance use disorder in the next month * Have a planned/scheduled surgery in next 12 months related to pain condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) | Baseline to 3 months | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MCID in Pain Severity at 6 Months (Yes / No) | Baseline to 6 months | Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary) Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity. |
| MCID in Pain Severity at 12 Months (Yes / No) | Baseline to 12 months | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. \[Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.\] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (\> or =30% improvement) in pain severity. |
| Pain Severity Score | Baseline to 3, 6 and 12 months | Modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity |
| Pain Intensity Score | Baseline to 3, 6, and 12 months | 4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity |
| Pain-related Interference Score | Baseline to 3, 6 and 12 months | 7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference |
| Social Role Functioning | Baseline to 3, 6 and 12 months | PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in ability to participate. |
| Physical Functioning | Baseline to 3, 6 and 12 months | PROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (\< 30) limitations in physical functioning. |
| Patient Global Impression of Change (PGIC) - Pain | Primary: Baseline to 3, 6 and 12 months | One item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain |
| Patient Global Impression of Change (PGIC) - General | Baseline to 3, 6 and 12 months | One item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLynn L DeBar, PhD, MPH
Kaiser Permanente
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 14.3 |
| Age, Customized Age 65 years and older | 900 Participants |
| Race/Ethnicity, Customized Missing | 25 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : American Indian / Alaska Native | 6 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Asian | 27 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Black or African American Non-Hispanic | 350 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Hispanic | 77 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : More than one race | 21 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Native Hawaiian / Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : White Non-Hispanic | 573 Participants |
| Region of Enrollment United States | 2331 participants |
| Rural/medically underserved residency | 1030 Participants |
| Sex: Female, Male Female | 571 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 776 | 7 / 778 | 7 / 777 |
| other Total, other adverse events | 1 / 776 | 16 / 778 | 0 / 777 |
| serious Total, serious adverse events | 55 / 776 | 65 / 778 | 63 / 777 |
Outcome results
None listed