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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Chronic Pain Self Management Program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioral Therapy<br>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<br>* 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.<br>|
| Active Comparator: Chronic Pain Self Management Program<br>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<br>* 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<br>|
| Placebo Comparator: Taper Only (Usual Care)<br>Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention. | Other: Usual Care<br>* Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.<br>|
| No Intervention: Observational Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Percent reduction (0-100%) of patient prescribed Morphine Equivalent Daily Dose (MEDD). | Baseline and 12 months | 
| 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 |