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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT05754190
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 20, 2023
Status verified
Sep 2025
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Healthy Controls
    \[general study + sub study\] No history of chronic pain
  • Arm: Acute pain
    \[general study\] Pain duration \< 3 months
  • Arm: Chronic pain
    \[general study\] Pain duration \> 6 months \[sub-study\] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia

Primary Outcome Measure

[General Study] Acute-Chronic Pain Transition Probability [ Time Frame: T1 [4 months of daily app use] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02912
Frederike H Petzschner, PhD
[email protected]
401-863-6272
Chloe S Zimmerman, MD/PhD Student
[email protected]
401-863-6272
Frederike H Petzschner, PhD (PRINCIPAL_INVESTIGATOR)

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