Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT03445988
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Study Start: 2018-07-24
• Primary Completion: 2023-11-06
• Study Completion: 2023-11-06
• Results First Submitted: 2025-01-30
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Results First Posted: 2025-03-24
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1462

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioid Tapering Success	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States