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New treatment option for Fibromyalgia
Official title Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
ClinicalTrials.gov ID: NCT05962437
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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):
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- Sant Boi de Llobregat, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; Sant Boi de Llobregat, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.