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Completed

NCT Number: NCT07032519

Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App

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.

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Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Brigham and Women's Hospital Department of Anesthesiology

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Intervention

Behavioral

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

Primary outcomes

  1. Change in Brief Pain Inventory

    Time frame: Daily for 8-weeks

    Assessed using the Brief Pain Inventory - Pain Interference Subscale

Secondary outcomes

  1. Change in Fibromyalgia Symptoms (FIQR)

    Time frame: Weekly for 8-weeks

    Assessed using the Fibromyalgia Impact Questionnaire Revised

  2. Change in Pain Catastrophizing (PCS)

    Time frame: Baseline and post (8 weeks)

    Assessed using the Fibromyalgia Impact Questionnaire Revised

  3. Pain Acceptance (CPAQ-R)

    Time frame: Baseline and post (8 weeks)

    Assessed using the Chronic Pain Acceptance Questionnaire Revised

  4. Mindfulness (MAAS)

    Time frame: Baseline and post (8 weeks)

    Assessed using the Mindful Attention Awareness Scale

  5. Anxiety and Depression (PROMIS-A/D)

    Time frame: Baseline and post (8 weeks)

    Assessed using PROMIS Anxiety and Depression short forms

  6. Qualitative Exit Interviews

    Time frame: Post (after 8-weeks)

    open-ended exit questionnaire

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: Fibroapp

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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