Single Session Class to Reduce Opioid Use in Chronic Pain

Study Overview
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Brief Summary
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Prescription opioids are one of the most commonly used treatments for chronic pain, despite limited evidence of their efficacy and high morbidity and mortality risks. The study aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.

Detailed Description
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The opioid epidemic is a serious national crisis that affects public health as well as social and economic welfare, with increasing and alarming mortality rates in the United States. Consequently, there is an urgent need for effective and efficient interventions to address opioid use to prevent the risk of opioid misuse and better address it once it is established. One of the greatest predictors for increased opioid use among patients with chronic pain is pain catastrophizing (PC), defined as persistent negative cognitive and emotional responses to actual or anticipated pain. Untreated PC can lead to increased opioid use and facilitate the risk for misuse and overuse of medications, particularly when surgery and pharmacologics are the focal medical care plan. Despite critical need, there are no targeted interventions that efficiently address the key psychological factors that can amplify both pain, need for opioids, and increased risk for misuse. This project aims to address this urgent need for efficient and effective solutions. A 2-hour targeted, single-session pain catastrophizing class (PC-class) has been developed, rooted in cognitive-behavior therapy (CBT) approaches, aimed at reducing opioid use by reducing pain catastrophizing in chronic pain. This targeted, brief treatment obviates many of the existing barriers and burdens to usual comprehensive pain-CBT, such as the time required to attend 8 sessions, insurance coverage, travel costs, lack of skilled clinicians, patient attrition, and copayments. The investigators will implement a randomized controlled trial comparing the PC-class to a health education control class. Aim 1, To determine the efficacy of the PC class in reducing opioid use among patients with mixed-etiology pain conditions. Aim 2, To collect daily data that will allow the conduct of analyses on the daily experience of catastrophizing and how it relates to opioid use, as well as its dynamic response to treatment. The investigators will use this daily data to characterize the mechanistic influence of catastrophizing on opioid use both on the daily-level and prospectively. Patient outcomes will be longitudinally tracked at 1, 3, 6, and 12 months after the intervention session. This project aims to identify patients who achieve a meaningful reduction in opioid use, which will enable better characterization of treatment responders and refining opioid reduction strategies.

Official Title
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Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Pain Catastrophizing Class
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age Diagnosis of chronic non-cancer pain (> 3 months in duration) Currently using prescription opioids ≥ 20mg morphine equivalent daily dose (MEDD) for ≥ 3 months; Ability and willingness to complete study procedures. Exclusion Criteria: Open litigation regarding a medical condition Inability to provide informed consent and complete study procedures Active suicidality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Catastrophizing Class<br>A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. | Behavioral: Pain Catastrophizing Class<br>* A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.<br>|
| Placebo Comparator: Health Education<br>A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community. | Behavioral: Health Education<br>* Education about improving lifestyle factors to improve participants' overall health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | Clinically minimal reduction is defined as >15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing Score; measured with Pain Catastrophizing Scale | Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention | 12 months |