[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513205":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":56,"responsibleParty":104,"collaborators":106,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":31,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":31,"overallStatus":82,"whyStopped":31,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Fundació Sant Joan de Déu","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"STANZA-Spain","EXPERIMENTAL","Digital Acceptance and Commitment Terapy (ACT). It consists of 41 structured ACT lessons, incorporating mindfulness practices and daily activities to facilitate behavior change and promote gradual pacing of daily activities and exercise. The core content was designed to be completed within 8 weeks, with a 4-week maintenance period thereafter to strengthen skills.",[13,14],"Device: Self-guided digital Acceptance and Commitment Therapy","Behavioral: Treatment as Usual (TAU)",{"label":16,"type":17,"description":18,"interventionNames":19},"FibroST-Spain","ACTIVE_COMPARATOR","A digital active control intervention is implemented to control for study engagement, expectations, and healthcare provider interaction biases. Components of this active comparator include daily symptom and function tracking (Daily Symptom Tracker), symptom and function monitoring, and access to health education articles about fibromyalgia.",[20,14],"Device: FM symptom tracking app (FM-ST)",{"label":22,"type":17,"description":23,"interventionNames":24},"Treatment as Usual (TAU)","Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling.",[14],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Self-guided digital Acceptance and Commitment Therapy","Smartphone-based mobile health application (app) that delivers a self-guided, evidence-based ACT program tailored to the management of FM. This investigational digital therapeutic, referred to herein as STANZA, was inspired by a web-based ACT program for FM validated by University of Manitoba and was recently granted De Novo clearance by the U.S. FDA. The app delivers ACT in 15- to 20-minute daily doses over the course of 12 weeks with minimal involvement of healthcare providers. The program consists of interactive educational materials that teach ACT skills which are reinforced experientially via values exploration and identification, mindfulness, and relaxation exercises. Values-based assignments follow each lesson to assist patients in incorporating ACT skills into their daily lives. Uniquely, STANZA teaches additional skills, including self-guided physical exercise and pacing daily activities via a personally customized stepwise, gradual approach.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"FM symptom tracking app (FM-ST)","Based on the same platform as STANZA, FM-ST enables self-guided daily tracking of patient-reported symptoms and functioning. Symptom tracking is commonly used in chronic pain management. FM-ST also provides access to educational materials relevant to FM and general health but does not provide any psychotherapy or healthcare professional involvement. This app mitigates potential expectation, treatment time and attention, and healthcare provider interaction biases that often occur in chronic pain studies that utilize passive comparison conditions.",[16],{"type":37,"name":22,"description":38,"armGroupLabels":39,"otherNames":31},"BEHAVIORAL","Usual care is mainly carried out by general practitioners and specialists in regular consultations, commonly consisting of face-to-face visits to monitor the physical and emotional status of the patient. Clinicians usually provide advice about physical exercise, diet, etc., and prescribe pharmacotherapy (pain medications, hypnotics and antidepressants)",[16,9,22],[41],{"name":42,"affiliation":43,"role":44},"Juan V Luciano, PhD","Universitat Autònoma de Barcelona (UAB) & FSJD","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Jaime Navarrete, PhD","CONTACT","+34936406350","2543","jaime.navarrete@sjd.es",{"name":53,"role":48,"phone":54,"phoneExt":31,"email":55},"Paula Ponce López, Msc","+34678758047","paula.poncel@sjd.es",[57,80],{"facility":58,"status":59,"city":60,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Hospital Vall d'Hebrón","NOT_YET_RECRUITING","Barcelona","08035","Spain","ES",{"type":65,"coordinates":66},"Point",[67,68],2.15899,41.38879,{"lat":68,"lon":67},[71,76,77],{"name":72,"role":48,"phone":73,"phoneExt":74,"email":75},"Mayte Serrat, PhD","+34934863000","3361","mayte.serrat@vallhebron.cat",{"name":72,"role":44,"phone":31,"phoneExt":31,"email":31},{"name":78,"role":79,"phone":31,"phoneExt":31,"email":31},"Miriam Almirall, MD, PhD","SUB_INVESTIGATOR",{"facility":81,"status":82,"city":83,"state":60,"zip":84,"country":62,"countryCode":63,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Parc Sanitari Sant Joan de Déu (PSSJD)","RECRUITING","Sant Boi de Llobregat","08830",{"type":65,"coordinates":86},[87,88],2.03659,41.34357,{"lat":88,"lon":87},[91,94,98,99,100,102],{"name":42,"role":48,"phone":49,"phoneExt":92,"email":93},"2540","juanvicente.luciano@sjd.es",{"name":95,"role":48,"phone":96,"phoneExt":31,"email":97},"Antoni Rozadilla-Sacanell, MD, PhD","+34936615208","antoni.rozadilla@sjd.es",{"name":42,"role":44,"phone":31,"phoneExt":31,"email":31},{"name":95,"role":79,"phone":31,"phoneExt":31,"email":31},{"name":101,"role":79,"phone":31,"phoneExt":31,"email":31},"Jaime Navarrete-Hidalgo, PhD",{"name":103,"role":79,"phone":31,"phoneExt":31,"email":31},"Paula Ponce López, MSc",{"type":105,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[107],{"name":108,"class":6},"Swing Therapeutics, Inc.","100513205","self-guided-acceptance-and-commitment-therapy-based-digital-smartphone-application-for-management-of-fibromyalgia-100513205",false,"NCT05962437","Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia","Three-arm Randomized Controlled Trial Investigating the Effectiveness, Cost-utility, and Physiological Effects of the Spanish Version of STANZA®: A Self-guided Digital Acceptance and Commitment Therapy (ACT) for Fibromyalgia","SMART-FM-SP","Inclusion Criteria:\n\n* Fibromyalgia diagnosis according to the 2016 ACR criteria\n* Fibromyalgia Impact Questionnaire Revised (FIQR) total score within the range of 35-80 at baseline.\n* Willing to maintain their current pain treatment throughout the study.\n* Having a smartphone (iOS 12 or higher or Android OS 8 or higher).\n* Proficient understanding of Spanish.\n\nExclusion Criteria:\n\n* Presence of cognitive impairment according to clinical records.\n* Diagnosis of severe medical or mental disorders such as cancer, psychotic disorder, and drug abuse according to medical records.\n* Patients at risk of suicide.\n* Being pregnant or planning a pregnancy during the study period, or currently breastfeeding.\n* Participation in other clinical trials during the study or within the previous 12 months.\n* Unable to use a smartphone.\n\nExclusion criteria for biomarkers substudy (30-50 patients in each study arm):\n\n* Male sex\n* Comorbid rheumatologic disorders such as lupus or severe organ dysfunction.\n* History of fever (\\> 38ºC) or infection within the last 2 weeks.\n* Vaccination within the last 4 weeks.\n* Recent physical trauma\n* Needle phobia.\n* Consumption of more than 8 units of caffeine per day.\n* Smoking more than 5 cigarettes per day.\n* Current use of oral or topical corticosteroids.\n* Current use of anti-cytokine biologic medications.\n* Current use of oral contraceptives.","ALL","18 Years","70 Years",{"count":121,"type":122},360,"ESTIMATED","INTERVENTIONAL",[125],"NA","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.\n\nMethodology: 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.\n\nDiscussion: 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.",[128],"Fibromyalgia","2026-07-21",{"date":131,"type":132},"2026-07-23","ACTUAL",{"date":134,"type":132},"2024-01-01",{"date":136,"type":122},"2027-03-31",{"name":5,"class":6},2]