RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-20
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05754190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Frederike H Petzschner, PhD
CONTACT
401-863-6272
frederike_petzschner@brown.edu
Chloe S Zimmerman, MD/PhD student
CONTACT
401-863-6272
chloe_zimmerman@brown.edu

Principal Investigator

Frederike H Petzschner, PhD
PRINCIPAL_INVESTIGATOR
Brown University

Study Locations (Sites)

Brown University
Providence, Rhode Island, 02912
United States

Collaborators and Investigators

Sponsor: Brown University

  • Frederike H Petzschner, PhD, PRINCIPAL_INVESTIGATOR, Brown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • digital health
  • e-health
  • smartphone application
  • chronic pain
  • acute pain
  • symptom tracking
  • experience sampling methodology
  • ecological momentary assessment
  • pain self-management

Additional Relevant MeSH Terms

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