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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445988
• Other study ID #: 44918
• Status: Completed
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: November 6, 2023

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1371
• Est. completion date: November 6, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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

Other:
• Usual Care
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Locations

Country	Name	City	State
United States	Stanford University (empower.stanford.edu)	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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