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RECRUITING

NCT05754190

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

Sponsor: Brown University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2023-06-20

Completion Date

2026-05-30

Last Updated

2025-09-19

Healthy Volunteers

Yes

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.

INCLUSION CRITERIA \[General study\] * Chronic pain group: * Age above 18 * Access to a personal smartphone and a stable internet connection * Average pain intensity score of greater than 3 in the past week or * Average pain interference score of greater than 3 in the past week or * Average pain distress score of greater than 3 in the past week * Pain duration: greater than 6 months * Acute pain group: * Age above 18 * Access to a personal smartphone and a stable internet connection * Average pain intensity score of greater than 3 in the past week ○ or * Average pain interference score of greater than 3 in the past week ○ or * Average pain distress score of greater than 3 in the past week * Pain duration: less than 3 months * Pain cause: Due to recent surgery, injury, acute illness, or childbirth (within the past 3 months) * Healthy control group: * Age above 18 * Access to a personal smartphone and a stable internet connection * Average pain intensity score of less than 3 in the past week * Average pain interference score of less than 3 in the past week * Average pain distress score of less than 3 in the past week * No surgery, injury, acute illness, or childbirth (within the past 3 months) * In person EEG testing \[Sub-Study only\]: * Same as in General App Study Above and additionally: * Current diagnosis of Fibromyalgia, Chronic Low Back Pain or Failed Back Surgery Syndrome OR * No current or prior history of chronic pain * If participant has chronic low back pain or failed back surgery syndrome: are they planning to have either a radio-frequency ablation, back surgery, or spinal cord stimulation implant in the next few months * If participant has chronic low back pain or failed back surgery syndrome: have they received insurance approval for the procedure? * Ok with EEC/ECG measures EXCLUSION CRITERIA \[General study\] * Chronic pain group: * recent injury or surgery unrelated to the pain in the past 3 months * difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation); * Not fluent in English (difficulty understanding questions) * Current primary or metastatic cancer (organic cause of pain) * Acute pain group: * History of Chronic Pain (Pain lasting for more than 6 months) * difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation); * Not fluent in English (difficulty understanding questions) * Current primary or metastatic cancer (organic cause of pain) * Healthy control group: History of Chronic Pain (Pain lasting for more than 6 months) * difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation); * Not fluent in English (difficulty understanding questions) -In person EEG testing \[Sub-study only\]: \[will interfere with EEG data collection safety or quality\]: * Same as in General App Study Above and additionally: * Baldness * Pregnancy * Dreadlocks * Left-handedness * Use of a wheelchair * Heart failure diagnosis * Current or prior experience with acute psychosis or mania * implanted pacemaker, neurostimulator or any other head or heart implants * require a hearing aid to hear properly * claustrophobia * metal fragments in the body

Locations (1)

Brown University

Providence, Rhode Island, United States