RecruitingNCT05754190

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA


Sponsor

Brown University

Enrollment

800 participants

Start Date

Jun 20, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a smartphone application called SOMA to track how pain intensity, mood, and daily symptoms fluctuate over time in real-world conditions. Rather than relying on infrequent clinic visits, the app captures repeated 'snapshots' of a participant's experience throughout the day and week. The study includes people with chronic pain (lasting more than 6 months), those with recent acute pain (from surgery, injury, or illness within the past 3 months), and healthy volunteers as a comparison group. All participants must be 18 or older, have a smartphone and internet access, and be able to communicate in English. Chronic pain participants must report significant pain intensity, interference, or distress. Healthy controls must have minimal pain and no history of chronic pain. An optional sub-study involving in-person EEG brain recordings is available for people with fibromyalgia, chronic low back pain, or no pain history. Those with active cancer, no smartphone access, or difficulty committing to the study are excluded. Participants will use the SOMA app to complete brief daily check-ins for up to four months. This research matters because understanding how pain fluctuates day to day — and how it links to mood — could fundamentally change how we measure, treat, and manage chronic pain in the future.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESOMA pain manager smartphone application

SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.


Locations(1)

Brown University

Providence, Rhode Island, United States

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NCT05754190


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