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Table of Contents

  • Introduction
  • The Need for Large-Scale Studies
  • The Pragmatic Clinical Studies Initiative
  • Understanding Chronic Pain and its Impact
  • Cognitive Behavioral Therapy for Chronic Pain
  • Introducing Empowered Relief: A One-Session Approach
  • Comparing Empowered Relief with Online CBT
  • The Research Process and Study Design
  • Key Outcomes and Measures
  • Enhancing Diversity and Health Equity
  • Conclusion
  • References

Introduction

Chronic pain affects over 50 million Americans, causing significant physical and emotional distress. Traditional approaches to managing chronic pain often involve multiple sessions of cognitive behavioral therapy (CBT), which can be challenging for some patients to complete. In an effort to explore alternative treatment options, researchers have initiated a study to evaluate the effectiveness of a single-session class on pain relief skills called Empowered Relief. This article delves into the study’s objectives, methods, and potential implications for the management of chronic pain.

The Need for Large-Scale Studies

The Patient-Centered Outcomes Research Institute (PCORI) recognizes the importance of conducting large-scale studies that address real-life questions faced by diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative, which aims to support comparative effectiveness studies focusing on everyday care for a wide range of patients. The initiative has provided funding for research projects such as the evaluation of Empowered Relief for chronic pain management.

The Pragmatic Clinical Studies Initiative

The Pragmatic Clinical Studies initiative, introduced by PCORI, seeks to bridge the gap between research and practice. By funding studies that explore the effectiveness of different treatment approaches in real-world settings, PCORI aims to provide evidence-based guidance to healthcare professionals and patients. The initiative emphasizes the importance of patient engagement in the research process, ensuring that study outcomes are relevant and applicable to diverse populations.

Understanding Chronic Pain and its Impact

Chronic pain is characterized by persistent pain that lasts for months or even years. It can significantly impact an individual’s quality of life, limiting their ability to perform daily tasks and affecting their emotional well-being. To address the complex nature of chronic pain, researchers have turned to cognitive behavioral therapy (CBT), a proven approach that focuses on changing patterns of thinking to improve pain management.

Cognitive Behavioral Therapy for Chronic Pain

CBT has gained recognition as an effective treatment for chronic pain. By targeting cognitive processes and behavioral strategies, this therapy helps patients develop coping skills and change their response to pain. However, traditional CBT programs often involve multiple sessions, making them challenging for some patients to complete. Recognizing the need for a more accessible approach, researchers have developed a single-session class called Empowered Relief.

Introducing Empowered Relief: A One-Session Approach

Empowered Relief is a two-hour online class that provides patients with the necessary skills to manage chronic pain effectively. Led by a certified instructor, the class covers various pain relief techniques, including relaxation techniques and self-soothing strategies. By condensing the content into one session, Empowered Relief aims to reach a broader population of patients who may find it difficult to commit to multiple sessions of therapy.

Comparing Empowered Relief with Online CBT

To evaluate the effectiveness of Empowered Relief, researchers have designed a randomized controlled trial involving 1,650 adults with chronic pain. These participants are assigned, by chance, to receive either the Empowered Relief class or eight sessions of online CBT. The study aims to compare the reduction in chronic pain experienced by participants in both groups and assess the impact on their daily functioning and healthcare utilization.

The Research Process and Study Design

The research team is collaborating with six study sites across the United States to recruit participants for the study. Patients enrolled in the study are asked to rate their pain levels and assess how pain interferes with their daily tasks at multiple time points, including before the intervention and at one, two, three, and six months after the intervention. Additionally, the research team compares participants’ healthcare utilization in the three months prior to the study with the last three months of the study period.

Key Outcomes and Measures

The primary outcomes of the study include pain intensity and pain interference, which are assessed using validated scales. Secondary outcomes encompass various aspects of pain management, such as sleep disturbance, level of pain bothersomeness, pain catastrophizing, anxiety, satisfaction with social roles and responsibilities, patient global impression of change, depression, fatigue, and anger. These measures provide a comprehensive assessment of the impact of Empowered Relief and online CBT on patients’ overall well-being.

Enhancing Diversity and Health Equity

Recognizing the importance of diversity and health equity, the study has received funding to promote meaningful engagement of affected communities. By ensuring a diverse and inclusive study population, the research aims to address potential healthcare disparities and provide insights that are relevant to all individuals living with chronic pain. Collaboration with patients, health insurers, and professional groups further enhances the study’s ability to capture the perspectives and needs of various stakeholders.

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