FibromyalgiaFibroappNCT07032519
Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App
A study testing Mindfulness Intervention in people with Fibromyalgia, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Brigham and Women's Hospital Department of Anesthesiology
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Being tested
- Mindfulness Intervention
- Keywords
- Mindfulness, Pain, mHealth, Chronic Pain
- Medical subject headings
- Fibromyalgia, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness InterventionBehavioural
Participants will use the smartphone app daily for pain tracking and weekly to engage with mindfulness content and complete additional assessments.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention (MBI) | Experimental | 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. Receives: Behavioral: Mindfulness Intervention |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory
Assessed using the Brief Pain Inventory - Pain Interference Subscale
Measured: Daily for 8-weeks
Secondary outcomes (6)
Change in Fibromyalgia Symptoms (FIQR)
Assessed using the Fibromyalgia Impact Questionnaire Revised
Measured: Weekly for 8-weeks
Change in Pain Catastrophizing (PCS)
Assessed using the Fibromyalgia Impact Questionnaire Revised
Measured: Baseline and post (8 weeks)
Pain Acceptance (CPAQ-R)
Assessed using the Chronic Pain Acceptance Questionnaire Revised
Measured: Baseline and post (8 weeks)
Mindfulness (MAAS)
Assessed using the Mindful Attention Awareness Scale
Measured: Baseline and post (8 weeks)
Anxiety and Depression (PROMIS-A/D)
Assessed using PROMIS Anxiety and Depression short forms
Measured: Baseline and post (8 weeks)
Qualitative Exit Interviews
open-ended exit questionnaire
Measured: Post (after 8-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start3 May 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asimina Lazaridou, PhD, Brigham and Women's Hospital
- Investigators
- Asimina Lazaridou, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032519
- Sponsor's protocol ID
- 2023P001410
- Acronym
- Fibroapp
- Status last verified
- Jan 2026
- First submitted
- 15 Jun 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention for Fibromyalgia Delivered Through a Smartphone App
- ClinicalTrials.gov ID
- NCT07032519
- Acronym / sponsor ID
- Fibroapp / 2023P001410
- Conditions
- Fibromyalgia
- Keywords
- Mindfulness, Pain, mHealth, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention (MBI) | Experimental | Behavioral: Mindfulness InterventionParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness InterventionParticipants will use the smartphone app daily for pain tracking and weekly to engage with mindfulness content and complete additional assessments. | Behavioural | Mindfulness-Based Intervention (MBI) |
Primary outcome
Change in Brief Pain Inventory
Time frame: Daily for 8-weeks
Assessed using the Brief Pain Inventory - Pain Interference Subscale
6 secondary outcomes
Change in Fibromyalgia Symptoms (FIQR)
Time frame: Weekly for 8-weeks
Change in Pain Catastrophizing (PCS)
Time frame: Baseline and post (8 weeks)
Pain Acceptance (CPAQ-R)
Time frame: Baseline and post (8 weeks)
Mindfulness (MAAS)
Time frame: Baseline and post (8 weeks)
Anxiety and Depression (PROMIS-A/D)
Time frame: Baseline and post (8 weeks)
Qualitative Exit Interviews
Time frame: Post (after 8-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asimina Lazaridou, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention in people with Fibromyalgia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Pain Inventory (time frame: Daily for 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.