Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
NCT ID: NCT05962437
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2024-01-01
2025-12-31
Brief Summary
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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 mainly at Vall d'Hebron University Hospital (Barcelona, Spain), and 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 and 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. Biomarkers will be assessed at baseline and post-treatment including hair cortisol, cortisone, corticosteroid binding globulin (CBG), adrenocorticotropic hormone (ACTH), cortisol in plasma, genotyping of FKBP5 gene polymorphisms, immune-inflammatory markers, and vitamin D levels.
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.
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Detailed Description
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Smart-FM-SP is a 6-months RCT with three arms: TAU, TAU+STANZA and TAU+FibroST. Therefore, patients in three arms will receive TAU, and FibroACT and FibroST will be complementary treatments to the standard one provided in the public Catalan Health System.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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STANZA-Spain
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.
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 without the 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.
Treatment as Usual (TAU)
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)
FibroST-Spain
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.
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.
Treatment as Usual (TAU)
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)
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.
Treatment as Usual (TAU)
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)
Interventions
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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 without the 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.
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.
Treatment as Usual (TAU)
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)
Eligibility Criteria
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Inclusion 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
* 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 90 days.
* Unable to use a smartphone.
* Comorbid rheumatologic disorders such as lupus.
* History of fever (\> 38ºC), or infection within the last 2 weeks.
* Recent vaccination within the last 4 weeks.
* Needle phobia.
* Consumption of more than 8 units of caffeine per day.
* Smoking more than 5 cigarettes per day.
* Having hair length less than 3 cm.
18 Years
70 Years
ALL
No
Sponsors
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Swing Therapeutics, Inc.
OTHER
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Principal Investigators
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Juan V Luciano, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Autònoma de Barcelona (UAB) & FSJD
Locations
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Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.
Other Identifiers
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PI22/00829
Identifier Type: -
Identifier Source: org_study_id
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