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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Chronic Pain Self Management Program; Other: Taper Only

• Study Type: Interventional
• Enrollment (Actual): 1462
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Taper + 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.	Behavioral: 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.
Active Comparator: Taper + 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.	Behavioral: 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. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session
Placebo Comparator: Taper Only (no assigned behavioral treatment); Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.	Other: Taper Only; Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
No Intervention: National Observational Study (non-randomized); The national observational arm of the study (the VALUE study) will enroll participants with chronic pain taking at least 10 MEDD daily. No interventions of any kind will be applied and only self-report survey data will be collected for the year following consent. EMPOWER (randomized trial) and VALUE are two independent studies. Data from the two studies will be analyzed separately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Tapering Success	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.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Beth Darnall, Ph.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): November 6, 2023

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: opioid, taper, behavioral treatment for pain, randomized
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 44918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No