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

• ClinicalTrials.gov Identifier: NCT03445988
• Recruitment Status: Active, not recruiting
• First Posted: February 26, 2018
• Last Update Posted: February 13, 2023
• Sponsor: Stanford University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Beth Darnall, Stanford University

Tracking Information

• First Submitted Date: February 15, 2018
• First Posted Date: February 26, 2018
• Last Update Posted Date: February 13, 2023
• Actual Study Start Date: July 24, 2018
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2018)

• Opioid use [ Time Frame: 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 [ Time Frame: Baseline and 12 months ]
  Patient self-reported pain intensity on 11 point (0-10) numerical rating scale (NRS).

Original Primary Outcome Measures (submitted: February 20, 2018)

• Opioid use [ Time Frame: Baseline and 12 months ]
  Change in opioid use
• Pain [ Time Frame: Baseline and 12 months ]
  Change in PROMIS Pain Intensity questionnaire

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• 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
• Other: Usual Care
  Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Study Arms

• Active Comparator: 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.
  Intervention: Behavioral: Cognitive Behavioral Therapy
• Active Comparator: 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.
  Intervention: Behavioral: Chronic Pain Self Management Program
• Placebo Comparator: Taper Only (Usual Care)
  Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
  Intervention: Other: Usual Care
• No Intervention: Observational Arm
  Participants that do not wish to reduce their opioid medications but are otherwise eligible and interested in the research study will be offered participation in the observational arm. The observational arm of the study will not include interventions of any kind and will only collect survey data for the year following consent.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 9, 2023): 1371
• Original Estimated Enrollment (submitted: February 20, 2018): 865
• Estimated Study Completion Date: November 30, 2023
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03445988
• Other Study ID Numbers: 44918
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Beth Darnall, Stanford University
• Original Responsible Party: Same as current
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Beth Darnall, Ph.D.; Stanford University

• PRS Account: Stanford University
• Verification Date: February 2023