Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962437
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-18
Brief Title:
Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-FM-SP
Brief 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 mainly at Vall dHebron 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
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 dHebron 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
Detailed Description:
Main goals of the SMART-FM-SP study The main objectives of this RCT are To analyze the effectiveness of adding Acceptance and Commitment Therapy via app STANZA compared to an active control arm Fibro Symptom Tracker app -FibroST- to the treatment as usual TAU for patients diagnosed of fibromyalgia To examine the cost-utility of STANZA from healthcare and societal perspectives To measure a set of biomarkers alongide the RCT in order to know the physiological underpinnings of the digital intervention STANZA and to identify potential predictors of treatment response
Smart-FM-SP is a 6-months RCT with three arms TAU TAUSTANZA and TAUFibroST 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
Smart-FM-SP is a 6-months RCT with three arms TAU TAUSTANZA and TAUFibroST 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None