RecruitingNot Applicable

Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia

Spain360 participantsStarted 2024-01-01

Plain-language summary

Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM. Methodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be recruited at Vall d'Hebron University Hospital (Barcelona, Spain), The Rheumatology Service of the Parc Sanitari Sant Joan de Déu (Sant Boi, Spain), The San Juan de Dios Hospital of Palma (Palma de Mallorca, Spain) and The San Juan de Dios Hospital of Aljarafe (Sevilla, Spain). They will be randomly allocated to one of the three study arms: Treatment as usual (TAU) plus STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be functional impairment, as measured by the FIQR; secondary outcomes will include patient impression of change, depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM. Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas ACT-related constructs, such as psychological flexibility, will be assessed to identify processes of change that will be analyzed with path analyses. Immune-inflamatory biomarkers will be assessed at baseline and post-treatment in 30-40 participants of each study arm. Additionally, a qualitative substudy using focus group thematic analysis will be conducted to deepen the understanding of STANZA app user experiences. Discussion: This study might represent a significant advancement in the management of FM in Spanish-speaking patients with FM, by examining the effectiveness, physiological effects, and cost-utility of a smartphone-based digital therapeutic with demonstrated empirical support in the United States of America.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fibromyalgia Impact Questionnaire Revised (FIQR)

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT05962437

SponsorFundació Sant Joan de Déu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Jaime Navarrete, PhD

+34936406350 jaime.navarrete@sjd.es

View on ClinicalTrials.gov More Fibromyalgia trials