Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App
CompletedNot applicableNCT07032519
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App
- Conditions
- Interventions
- Behavioral: Mindfulness Intervention
- Sponsor
- Brigham and Women's Hospital
- Start date
- 2024-05-03
- Primary completion
- 2025-08-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07032519