Status:
UNKNOWN
Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborating Sponsors:
Swing Therapeutics, Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-70 years
Phase:
NA
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, physiologic...
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 (Fi...
Eligibility Criteria
Inclusion
- 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
- 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 90 days.
- Unable to use a smartphone.
- Exclusion criteria for biomarkers substudy (50% of patients in each study arm):
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05962437
Start Date
January 1 2024
End Date
December 31 2025
Last Update
July 27 2023
Active Locations (2)
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1
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, Spain, 08830
2
Hospital Vall d'Hebrón
Barcelona, Spain, 08035