Empowered Relief trial evaluates if 1-session intervention is non-inferior to 8-session CBT for chronic painTrial Plans to Compare Short and Long Pain Interventions

Pain medicine (Malden, Mass.) Published July 7, 2026 Study authors: Adair Monson Emma, Mardian Aram, Saxena Kartikeya, Dorsonne Brittany, Hailu Arayam Y, Heggan Elizabe… PubMed ↗ NCT05612750 ↗ DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Note that this is a protocol only; no results are available to determine the efficacy of Empowered Relief.

This randomized comparative effectiveness study protocol describes a planned investigation into managing chronic pain in adults aged 18 years and older. The target population includes patients experiencing any type of pain for at least 3 months with a past-month intensity of 3/10 or greater. The trial is designed to recruit 1200 participants across 6 study sites, including an online telehealth component.

The primary objective is to determine if a single-session Empowered Relief (ER) behavioral intervention is non-inferior to an 8-session online Cognitive Behavioral Therapy (CBT) program. The primary outcomes measured are changes in pain intensity and pain interference from baseline to 3 months post-treatment. Secondary outcomes include sleep disturbance, pain catastrophizing, anxiety, and pain bothersomeness.

No results are currently available as the study is in the protocol stage. Safety data, including adverse events and tolerability, have not been reported. The trial will include a follow-up period of 6 months post-treatment. Because no data has been collected yet, these findings cannot currently inform clinical practice decisions regarding treatment selection for chronic pain.

Researchers are preparing a study to see if a very short treatment can work as well as a longer one for people with chronic pain. The study focuses on adults who have experienced persistent pain for at least three months and report significant discomfort in their daily lives.

The trial will compare two different online approaches. One group will receive a single session of an intervention called Empowered Relief. The other group will participate in eight sessions of Cognitive Behavioral Therapy. Both methods are designed to help patients manage their symptoms through behavioral techniques.

Because this is currently a protocol, no results have been collected yet. The study aims to see if the shorter program is just as effective as the longer one for reducing pain intensity and improving sleep. Since the trial has not started, these findings cannot be used to guide current medical decisions.

What this means for you:

This is a planned study to see if one session of therapy can match eight sessions for chronic pain management.

Common questions

What is being compared in this study?

The study compares a one-session online behavioral intervention called Empowered Relief to an eight-session online Cognitive Behavioral Therapy program. The goal is to see if the shorter treatment is just as effective for managing chronic pain as the longer series of sessions.

Who can participate in this study?

The study is designed for adults aged 18 and older who have experienced any type of pain for at least three months. Participants must also report a pain intensity of at least 3 out of 10 during the past month.

Are there results available from this trial yet?

No, results are not available yet because the study is currently in the protocol stage. This means the researchers have designed the plan and methods, but they have not yet conducted the sessions or collected data to see which treatment works better.

Study Details

Study typeRct

Sample sizen = 1

EvidenceLevel 2

PublishedJul 2026

PMID41712512

TrialNCT05612750

View Original Abstract ↓

INTRODUCTION: Evidence-based behavioral pain treatments are often inaccessible or infeasible for patients. A 1-session pain relief skills class (Empowered Relief; ER) has shown efficacy for multidimensional symptom reduction in various homogenous pain populations. Comparative effectiveness evidence in heterogeneous chronic pain is needed to inform decision-making and patient matching to treatment. OBJECTIVES: Conduct a non-inferiority comparative effectiveness trial of 2 evidence-based online (telehealth) behavioral group treatments for chronic pain (1-session ER vs 8-session CBT) in a nationally representative sample derived from 6 study sites. METHODS: 1200 adults ≥18 years of age with any type of pain ≥3 months with past-month intensity ≥3/10 will be recruited from 6 study sites. Participants are randomized 1:1 to either the online 1-session or the 8-session behavioral intervention. Patient-reported data are collected to 6 months post-treatment. Medical history, diagnoses, and healthcare utilization are obtained via medical records. MAIN OUTCOME MEASURES: Multi-primary outcomes are changes in pain intensity and pain interference from baseline to 3 months post-treatment with hypothesized non-inferiority between the 2 study treatments. Statistical analyses include mixed models for repeated measures (MMRM). Priority secondary outcomes include sleep disturbance, pain catastrophizing, anxiety, and pain bothersomeness. Exploratory heterogeneity of treatment effects will be examined. ETHICS AND DISSEMINATION: The study protocol was approved by all 6 site Institutional Review Boards including Stanford University School of Medicine (IRB 65439) as the coordinating site. Results will be published in peer-reviewed journals. PCORI (funder), participants, and advisors will receive summaries of the findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05612750.

Empowered Relief trial evaluates if 1-session intervention is non-inferior to 8-session CBT for chronic painTrial Plans to Compare Short and Long Pain Interventions

Common questions

Study Details

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Empowered Relief trial evaluates if 1-session intervention is non-inferior to 8-session CBT for chronic painTrial Plans to Compare Short and Long Pain Interventions

Common questions

Study Details

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