Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
The Brigham and Women's Hospital Department of Anesthesiology
RECRUITING
Boston
Contact Information
Primary
Timothy Wilkins
twilkins3@bwh.harvard.edu
+1 617-732-6368
Backup
Asimina Lazaridou, PhD
alazaridou@bwh.harvard.edu
617-243-6142
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2025-08
Participants
Target number of participants: 100
Treatments
Experimental: Mindfulness-Based Intervention (MBI)
Participants in this group will receive access to a smartphone app delivering an 8-week mindfulness-based intervention. The app includes weekly video modules (mindfulness practice and psychoeducation), daily pain tracking, and weekly assessments.
No_intervention: Control
Participants in this group will complete the same daily and weekly assessments via the smartphone app but will not have access to the mindfulness or psychoeducation content.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov