RECRUITING

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

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

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.

Official Title

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Quick Facts

Study Start:2024-05-03
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07032519

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 to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 to 65
  2. * Diagnosis of fibromyalgia per Wolfe et al. (2011) criteria
  3. * Stable medication regimen or medication-free
  4. * Fluent in English
  5. * Able to provide informed consent
  1. * Comorbid pain condition more severe than fibromyalgia
  2. * Pregnancy or breastfeeding
  3. * Current psychosis or history of severe psychiatric illness
  4. * Active suicidal ideation
  5. * Participation in another therapeutic trial
  6. * Any condition that may interfere with study compliance as judged by the PI or study coordinator

Contacts and Locations

Study Contact

Timothy Wilkins
CONTACT
+1 617-732-6368
twilkins3@bwh.harvard.edu
Asimina Lazaridou, PhD
CONTACT
617-243-6142
alazaridou@bwh.harvard.edu

Principal Investigator

Asimina Lazaridou, PhD
PRINCIPAL_INVESTIGATOR
Mass General Brigham

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Asimina Lazaridou, PhD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

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 Date2024-05-03
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-05-03
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Pain
  • mHealth
  • Chronic Pain

Additional Relevant MeSH Terms

  • Fibromyalgia