Single Session Class to Reduce Opioid Use in Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Pain Catastrophizing Class; Behavioral: Health Education

• Registration Number: NCT03950791
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-09-23
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Results First Submitted: 2024-07-17
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• 18-80 years of age
• Diagnosis of chronic non-cancer pain (> 3 months in duration)
• Currently using prescription opioids ≥ 10mg morphine equivalent daily dose (MEDD) for ≥ 3 months;
• Ability and willingness to complete study procedures.

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Exclusion Criteria

• Open litigation regarding a medical condition
• Inability to provide informed consent and complete study procedures
• Previous experience with cognitive behavioral therapy (CBT)
• Active suicidality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Catastrophizing Class	Pain Catastrophizing Class	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.
Health Education	Health Education	A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.

Primary Outcome Measures

Name	Time	Method
Opioid Use	baseline and 3 months	Clinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States