Status:

RECRUITING

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

Lead Sponsor:

Brown University

Conditions:

Chronic Pain

Acute Pain

Eligibility:

All Genders

18+ years

Brief 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 ov...

Detailed Description

The investigators aim to study the temporal dynamics of pain and links between self-reported pain, mood/emotion, and activities using the daily tracking app SOMA. The experience of pain fluctuates ove...

Eligibility Criteria

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

Key Trial Info

Start Date :

June 20 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 30 2026

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT05754190

Start Date

June 20 2023

End Date

May 30 2026

Last Update

September 19 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Brown University

Providence, Rhode Island, United States, 02912