Using a smartphone app to track pain and mood changes
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
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 type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05754190 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies utilizing digital health applications for pain management have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Frederike H Petzschner, PhD — Brown University
- Study coordinator: Frederike H Petzschner, PhD
- Email: frederike_petzschner@brown.edu
- Phone: 401-863-6272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.