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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Chronic Pain Self Management Program; Other: Usual Care

• 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.

To learn more about the EMPOWER study, please visit: empower.stanford.edu.

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
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1371

Inclusion Criteria

• Chronic non-cancer pain (≥ 6 months in duration)
• Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months

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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

To learn more about our recruitment, please visit: empower.stanford.edu.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.
Chronic Pain Self Management Program	Chronic Pain Self Management Program	The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Peers are people with chronic pain who live in the communities in which they teach. For this project, at least one peer facilitator per workshop will have had experience with prescription opioid use. Intervention fidelity is determined by having a trained observer with a checklist attend random workshop sessions. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session.
Taper Only (Usual Care)	Usual Care	Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Primary Outcome Measures

Name	Time	Method
Opioid use	Baseline and 12 months	Percent reduction (0-100%) of patient prescribed Morphine Equivalent Daily Dose (MEDD).
Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity	Baseline and 12 months	Patient self-reported pain intensity on 11 point (0-10) numerical rating scale (NRS).

Trial Locations

Locations (1)

Stanford University (empower.stanford.edu); 🇺🇸 Palo Alto, California, United States