Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Specific Aims Aim #1: Determine the effectiveness of a web-based CBT-CP 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. ...
Specific Aims Aim #1: Determine the effectiveness of a web-based CBT-CP 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 web-based 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.
Tracking Information
- NCT #
- NCT04523714
- Collaborators
- Essentia Health
- Georgia State University
- Duke University
- Northwestern University
- Investigators
- Principal Investigator: Lynn L DeBar, PhD, MPH Kaiser Permanente
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