Tailored Non-Pharmacotherapy Services for Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Virtual coach-led CBT-CP based programBehavioral: Online CBT-CP based program
- Registration Number
- NCT04523714
- Lead Sponsor
- Kaiser Permanente
- 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, 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2333
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual coach-led CBT-CP based program Virtual coach-led CBT-CP based program Live, 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 (no usual care services restricted) Online CBT-CP based program Online 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 (no usual care services restricted)
- Primary Outcome Measures
Name Time Method Achieving 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% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines) (binary). Range: 0 to 10. Higher score = worse pain severity.
- Secondary Outcome Measures
Name Time Method Social role functioning Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles 4A (4 items; continuous). Range: 4 to 20. Higher score = better ability to participate in social roles.
Physical functioning Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months PROMIS Physical Functioning Short Form 6b (6 items; continuous). Range: 0 to 6. Higher score = better physical functioning.
Cost and incremental cost-effectiveness Patient health care utilization costs from baseline to 12 months Health care utilization and intervention costs will be assessed.
Using the framework of cost-effectiveness, we will estimate the incremental cost per additional patient with a MCID in pain severity (30% reduction from baseline), at 12 months, and the quality-adjusted life year (QALY) gained-utilities will be estimated using the EQ-5D-5L.Achieving MCID in pain severity at 6 and 12 months (yes / no) Baseline to 6 and 12 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)
Pain severity Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months Modified 11-item version of the Brief Pain Inventory - Short Form ( BPI-SF); composite of pain intensity (4 items) and pain-related interference (7 items) subscales (11 items total; continuous)
Pain-related interference Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months Pain-related interference subscale of modified version of BPI-SF (7 items, continuous). Range: 0 to 10. Higher score = worse pain-related interference.
Pain intensity Baseline to 3, 6, and 12 months Pain intensity subscale of modified version of BPI-SF (4 items; continuous). Range: 0 to 10. Higher score - worse pain-related intensity.
Patient global impression of change (PGIC) Primary: Baseline to 3 months; Secondary: Baseline to 6 and 12 months Guy/Farrar Patient Global Impression of Change (1 item). Range: 0 to 6. High score = worse outcome.
Trial Locations
- Locations (4)
Kaiser Permanente Georgia, Center for Research and Evaluation
🇺🇸Atlanta, Georgia, United States
Essentia Institute of Rural Health
🇺🇸Duluth, Minnesota, United States
Kaiser Permanente Northwest Center for Health Research
🇺🇸Portland, Oregon, United States
Kaiser Permanente Washington Health Research Institute
🇺🇸Seattle, Washington, United States
Kaiser Permanente Georgia, Center for Research and Evaluation🇺🇸Atlanta, Georgia, United States