RECRUITING

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Description

The purpose of this pilot feasibility study is to evaluate the effects of a smartphone-based mindfulness intervention (MBI) on pain-related outcomes in individuals with fibromyalgia. This 8-week randomized controlled trial will compare an MBI app group to a control group who completes assessments only through the app. The MBI intervention includes weekly video content focused on mindfulness practice and psychoeducation, combined with daily symptom tracking through the app. Participants in both groups will complete self-report measures at baseline, post-intervention, and follow-ups at 3 and 6 months. The study will enroll up to 100 participants from Brigham and Women's Hospital and the greater Boston area. This pilot study is designed to assess feasibility and explore preliminary effects on outcomes such as pain interference, fibromyalgia symptoms, pain catastrophizing, sleep disturbance, emotional distress, mindfulness, and pain acceptance. Results will be used to inform the design of a future fully powered randomized trial.

Conditions

Study Overview

Study Details

Study overview

The purpose of this pilot feasibility study is to evaluate the effects of a smartphone-based mindfulness intervention (MBI) on pain-related outcomes in individuals with fibromyalgia. This 8-week randomized controlled trial will compare an MBI app group to a control group who completes assessments only through the app. The MBI intervention includes weekly video content focused on mindfulness practice and psychoeducation, combined with daily symptom tracking through the app. Participants in both groups will complete self-report measures at baseline, post-intervention, and follow-ups at 3 and 6 months. The study will enroll up to 100 participants from Brigham and Women's Hospital and the greater Boston area. This pilot study is designed to assess feasibility and explore preliminary effects on outcomes such as pain interference, fibromyalgia symptoms, pain catastrophizing, sleep disturbance, emotional distress, mindfulness, and pain acceptance. Results will be used to inform the design of a future fully powered randomized trial.

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Condition
Fibromyalgia
Intervention / Treatment

-

Contacts and Locations

Boston

The Brigham and Women's Hospital Department of Anesthesiology, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Asimina Lazaridou, PhD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

2025-08