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

NCT05754190 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Chronic Pain
  • Acute Pain
  • Post Operative Pain
  • Fibromyalgia, Primary
  • Fibromyalgia, Secondary
  • Fibromyalgia
  • Irritable Bowel Syndrome
  • Chronic Headache Disorder
  • Chronic Migraine
  • Chronic Pelvic Pain Syndrome
  • Temporomandibular Joint Disorders
  • Endometriosis-related Pain
  • Arthritis
  • Chronic Low-back Pain
  • Failed Back Surgery Syndrome
  • Post Herpetic Neuralgia
  • Neuropathic Pain
  • Painful Diabetic Neuropathy
  • Painful Bladder Syndrome
  • Trauma-related Wound
  • Trauma, Multiple
  • Chronic Pain Syndrome
  • Chronic Shoulder Pain

Interventions

DEVICE

SOMA 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.

Sponsors & Collaborators

  • Brown University

    lead OTHER

Principal Investigators

  • Frederike H Petzschner, PhD · Brown University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2026-05-30
Completion
2026-05-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754190 on ClinicalTrials.gov