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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445988
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : February 13, 2023
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Beth Darnall, Stanford University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Cognitive Behavioral Therapy Behavioral: Chronic Pain Self Management Program Other: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Pain Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
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.
 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: 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 (Usual Care)
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
 Other: Usual Care
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Opioid use [ Time Frame: Baseline and 12 months ]
    Percent reduction (0-100%) of patient prescribed Morphine Equivalent Daily Dose (MEDD).

  2. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445988


Locations
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United States, California
Stanford University (empower.stanford.edu)
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Beth Darnall, Ph.D. Stanford University
More Information
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Responsible Party: Beth Darnall, Clinical Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03445988    
Other Study ID Numbers: 44918
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations