Comparative Effectiveness of Pain Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Stanford University
- Enrollment
- 1462
- Locations
- 1
- Primary Endpoint
- Opioid Tapering Success
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care.
The aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (Taper Only).
The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief.
Investigators
Beth Darnall
Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Chronic non-cancer pain (≥ 6 months in duration)
- •Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months
Exclusion Criteria
- •Unable to provide informed consent
- •Unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of English fluency)
- •Moderate to severe opioid use disorder
Outcomes
Primary Outcomes
Opioid Tapering Success
Time Frame: Baseline and 12 months
Opioid tapering success was defined as either: 50% reduction in opioid dose (change in MEDD baseline to 12 months) and no significantly increased pain (≤ 1 point increase in PROMIS pain intensity score from baseline to 12 months), or; no opioid dose increase (baseline MEDD to 12 months) and significant pain relief (≥ 2 points decrease in PROMIS pain intensity score). Pain intensity score: Patient self-reported pain intensity on 11 point (0-10) numerical rating scale where a lower score means more pain relief. MEDD: Morphine Equivalent Daily Dose. PROMIS: Patient-Reported Outcomes Measurement Information System.