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

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Chronic Pain Self Management Program
Usual Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University (empower.stanford.edu)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Cognitive Behavioral Therapy

Chronic Pain Self Management Program

Taper Only (Usual Care)

Observational Arm

Arm Description

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.

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 15, 2018
Last Updated
February 9, 2023
Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03445988
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chronic Pain Self Management Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Taper Only (Usual Care)
Arm Type
Placebo Comparator
Arm Description
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
Arm Title
Observational Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Chronic Pain Self Management Program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
Primary Outcome Measure Information:
Title
Opioid use
Description
Percent reduction (0-100%) of patient prescribed Morphine Equivalent Daily Dose (MEDD).
Time Frame
Baseline and 12 months
Title
Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity
Description
Patient self-reported pain intensity on 11 point (0-10) numerical rating scale (NRS).
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Darnall, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University (empower.stanford.edu)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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