Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

NCT ID: NCT07032519

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2025-08-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Asimina Lazaridou, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asimina Lazaridou, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

The Brigham and Women's Hospital Department of Anesthesiology

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy Wilkins

Role: CONTACT

twilkins3@bwh.harvard.edu

+1 617-732-6368

Asimina Lazaridou, PhD

Role: CONTACT

alazaridou@bwh.harvard.edu

617-243-6142

Facility Contacts

Asimina Lazaridou, PhD

Role: primary

alazaridou@bwh.harvard.edu

617-243-6142

Other Identifiers

2023P001410

Identifier Type: -

Identifier Source: org_study_id