Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

Not Applicable

Recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT07032519
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Mindfulness-based interventions have shown promise in improving symptoms of chronic pain, including fibromyalgia, through mechanisms such as increased pain acceptance, reduced catastrophizing, and enhanced emotional regulation. Delivering such interventions via smartphone application increases accessibility and scalability, particularly for individuals who face mobility or geographic barriers to in-person treatment.

This study uses a parallel-group randomized controlled design. Participants will be assigned to either the MBI intervention group or a control group. The intervention group will receive access to weekly mindfulness practice and psychoeducation videos through a smartphone app over the course of 8 weeks, in addition to daily symptom tracking and weekly assessments. The control group will use the same app to complete assessments only.

Primary outcomes include feasibility and clinical variables including pain interference, fibromyalgia symptoms, and pain catastrophizing. Secondary outcomes include sleep disturbance, anxiety, depression, pain acceptance, and mindfulness.

Assessments will be collected at baseline and after the 8-week intervention, with additional follow-ups at 3 and 6 months post-intervention to examine sustained effects. All study procedures, including informed consent, intervention delivery, and assessments, will occur remotely through the app or secure platforms.

The results of this study will offer insight into the acceptability, engagement, and preliminary efficacy of smartphone-based mindfulness interventions for fibromyalgia and guide development of a larger confirmatory trial.

Study Timeline

• Study Start: 2024-05-03
• Status Verified: 2025-06
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-08
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain (BPI)	Daily for 8-weeks	Assessed using the Brief Pain Inventory - Pain Interference Subscale

Secondary Outcome Measures

Name	Time	Method
Pain Acceptance (CPAQ-R)	Baseline and post (8 weeks)	Assessed using the Chronic Pain Acceptance Questionnaire Revised
Mindfulness (MAAS)	Baseline and post (8 weeks)	Assessed using the Mindful Attention Awareness Scale
Change in Fibromyalgia Symptoms (FIQR)	Weekly for 8-weeks	Assessed using the Fibromyalgia Impact Questionnaire Revised
Anxiety and Depression (PROMIS-A/D)	Baseline and post (8 weeks)	Assessed using PROMIS Anxiety and Depression short forms
Qualitative Exit Interviews	Post (after 8-weeks)	open-ended exit questionnaire
Change in Pain Catastrophizing (PCS)	Baseline and post (8 weeks)	Assessed using the Fibromyalgia Impact Questionnaire Revised

Trial Locations

Locations (1)

The Brigham and Women's Hospital Department of Anesthesiology; 🇺🇸 Boston, Massachusetts, United States