Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

NCT07032519 | Completed

• 1 other identifier: 2023P001410
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Mindfulness; Pain; mHealth; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory

  Assessed using the Brief Pain Inventory - Pain Interference Subscale

  Daily for 8-weeks

Secondary Outcomes (6)

• Change in Fibromyalgia Symptoms (FIQR)

  Weekly for 8-weeks

• Change in Pain Catastrophizing (PCS)

  Baseline and post (8 weeks)

• Pain Acceptance (CPAQ-R)

  Baseline and post (8 weeks)

• Mindfulness (MAAS)

  Baseline and post (8 weeks)

• Anxiety and Depression (PROMIS-A/D)

  Baseline and post (8 weeks)

Study Arms (2)

Mindfulness-Based Intervention (MBI)

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention

Control

NO INTERVENTION

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.

Interventions

Mindfulness Intervention BEHAVIORAL

Participants will use the smartphone app daily for pain tracking and weekly to engage with mindfulness content and complete additional assessments.

Mindfulness-Based Intervention (MBI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

The Brigham and Women's Hospital Department of Anesthesiology

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asimina Lazaridou, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: This is a randomized controlled trial utilizing a parallel assignment model. Participants are randomly assigned to either the intervention group, which receives a smartphone-based mindfulness video series and daily pain rating prompts, or a control group that receives daily pain tracking only. The intervention is self-guided and delivered remotely via a secure smartphone app. Outcomes are measured at baseline, post-intervention, and 3- and 6-month follow-ups.

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: May 3, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)