Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using a smartphone app to track pain and mood changes

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

Run by Brown University · NCT05754190 · Data updated 2026-11-12

This study is testing a smartphone app to track pain and mood changes in people with chronic pain and healthy individuals to see how these factors affect pain over time.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorBrown University
Academic / other
Locations1 site (Providence, Rhode Island)
StatusRecruiting
StartedJune 20, 2023
Main results expectedMay 30, 2026
Study endsMay 30, 2026
Registry record updatedSeptember 19, 2025
Trial IDNCT05754190 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with either acute pain lasting less than 3 months or chronic pain lasting more than 6 months.

Probably not a fit

Patients with pain conditions that do not meet the specified criteria or those without access to a smartphone may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study utilizes the SOMA smartphone application to monitor daily mood, pain levels, and activity in individuals experiencing acute or chronic pain, as well as healthy controls, over a four-month period. The primary aim is to analyze fluctuations in self-reported symptoms to identify predictors for the transition from acute to chronic pain, pain recovery, and chronic pain maintenance. Participants will include those with chronic pain conditions, and a subset will undergo EEG testing to gather additional data on pain dynamics. The study seeks to understand how emotional states and life events influence pain experiences.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of pain, potentially aiding in the prevention of chronic pain development.

How similar studies have gone: Other studies utilizing digital health applications for pain management have shown promise, suggesting that this approach may yield valuable insights.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Brown University
    Providence, Rhode Island, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.