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Search / Trial NCT07032519

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jun 15, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Mindfulness Pain M Health Chronic Pain

ClinConnect Summary

This study is exploring whether using a smartphone app that teaches mindfulness—a way of paying attention to the present moment—can help people with fibromyalgia manage their pain and other symptoms. Over eight weeks, one group of participants will use the app to watch weekly videos about mindfulness and track their symptoms daily, while another group will only complete regular surveys through the app. The researchers want to see if this kind of app-based mindfulness program is practical and if it might improve things like pain, sleep, mood, and overall well-being.

Adults between 18 and 65 years old who have been diagnosed with fibromyalgia, are stable with their medications (or not taking any), and can read and understand English may be eligible to join. Participants should not have other more severe pain conditions, serious mental health issues, or be pregnant or breastfeeding. If you join, you’ll complete questionnaires about your symptoms at the start, after the 8-week program, and again at 3 and 6 months later. This study is a first step to see if this app could be helpful and to plan larger future studies.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults aged 18 to 65
  • Diagnosis of fibromyalgia per Wolfe et al. (2011) criteria
  • Stable medication regimen or medication-free
  • Fluent in English
  • Able to provide informed consent
  • Exclusion Criteria:
  • Comorbid pain condition more severe than fibromyalgia
  • Pregnancy or breastfeeding
  • Current psychosis or history of severe psychiatric illness
  • Active suicidal ideation
  • Participation in another therapeutic trial
  • Any condition that may interfere with study compliance as judged by the PI or study coordinator

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Asimina Lazaridou, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported