Fibromyalgia
Conditions
Keywords
Mindfulness, Pain, mHealth, Chronic Pain
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.
Interventions
BEHAVIORALMindfulness Intervention
Participants will use the smartphone app daily for pain tracking and weekly to engage with mindfulness content and complete additional assessments.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory | Daily for 8-weeks | Assessed using the Brief Pain Inventory - Pain Interference Subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Pain Catastrophizing (PCS) | Baseline and post (8 weeks) | Assessed using the Fibromyalgia Impact Questionnaire Revised |
| Qualitative Exit Interviews | Post (after 8-weeks) | open-ended exit questionnaire |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAsimina Lazaridou, PhD
Massachusetts General Hospital
Outcome results
None listed