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A smartphone app may ease fibromyalgia — a 360-person trial investigates

NCT ID NCT05962437

Symptom relief Sponsor: Fundació Sant Joan de Déu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a smartphone app called STANZA, which delivers a type of talk therapy known as acceptance and commitment therapy (ACT), can improve daily function and well-being in people with fibromyalgia. Researchers will compare three groups: those using the app plus usual care, those using a symptom-tracking app plus usual care, and those receiving usual care alone. The study aims to see if the app reduces pain-related disability and stress, and whether it is cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a smartphone app delivering self-guided acceptance and commitment therapy (ACT) for fibromyalgia management
What this could lead to
If effective, this digital therapy could offer a scalable, low-cost way to improve daily function and quality of life for people with fibromyalgia.
What could go wrong
This is an early-stage trial testing a digital tool against usual care; results may not show meaningful benefit, and the app requires daily engagement that not all users may maintain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Fibromyalgia diagnosis according to the 2016 ACR criteria * Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80 at baseline. * Willing to maintain their current pain treatment throughout the study. * Having a smartphone (iOS 12 or higher or Android OS 8 or higher). * Proficient understanding of Spanish. Exclusion Criteria: * Presence of cognitive impairment according to clinical records. * Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder, and drug abuse according to medical records. * Patients at risk of suicide. * Being pregnant or planning a pregnancy during the study period, or currently breastfeeding. * Participation in other clinical trials during the study or within the previous 12 months. * Unable to use a smartphone. Exclusion criteria for biomarkers substudy (30-50 patients in each study arm): * Male sex * Comorbid rheumatologic disorders such as lupus or severe organ dysfunction. * History of fever (\> 38ºC) or infection within the last 2 weeks. * Vaccination within the last 4 weeks. * Recent physical trauma * Needle phobia. * Consumption of more than 8 units of caffeine per day. * Smoking more than 5 cigarettes per day. * Current use of oral or topical corticosteroids. * Current use of anti-cytokine biologic medications. * Current use of oral contraceptives.

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Vall d'Hebrón

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Parc Sanitari Sant Joan de Déu (PSSJD)

    RECRUITING

    Sant Boi de Llobregat, Barcelona, 08830, Spain

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