Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05754190

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

Led by Brown University · Updated on 2025-09-19

800

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18
  • Access to a personal smartphone and a stable internet connection
  • For chronic pain group: average pain intensity, interference, or distress score greater than 3 in the past week and pain duration over 6 months
  • For acute pain group: average pain intensity, interference, or distress score greater than 3 in the past week, pain duration less than 3 months, and pain caused by recent surgery, injury, acute illness, or childbirth within past 3 months
  • For healthy control group: average pain intensity, interference, and distress scores less than 3 in the past week and no surgery, injury, acute illness, or childbirth within past 3 months
  • For in-person EEG sub-study: same as general study plus current diagnosis of Fibromyalgia, Chronic Low Back Pain, or Failed Back Surgery Syndrome or no current/prior chronic pain history
  • For EEG sub-study participants with chronic low back pain or failed back surgery syndrome: planning to have radio-frequency ablation, back surgery, or spinal cord stimulation implant soon and have insurance approval
  • Willingness to undergo EEG/ECG measures
Not Eligible

You will not qualify if you...

  • For chronic pain group: recent injury or surgery unrelated to pain in past 3 months
  • Difficulty participating due to technical or logistical issues (e.g., no computer, incompatible smartphone, inability to commit to 4 months)
  • Not fluent in English
  • Current primary or metastatic cancer causing pain
  • For acute pain group: history of chronic pain lasting more than 6 months
  • For healthy control group: history of chronic pain lasting more than 6 months
  • For EEG sub-study: baldness, pregnancy, dreadlocks, left-handedness, wheelchair use, heart failure diagnosis
  • Experience with acute psychosis or mania
  • Implanted pacemaker, neurostimulator, or other head or heart implants
  • Need for hearing aid
  • Claustrophobia
  • Metal fragments in the body

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 02912

Actively Recruiting

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Research Team

F

Frederike H Petzschner, PhD

CONTACT

C

Chloe S Zimmerman, MD/PhD student

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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