FibromyalgiaSMART-FM-SPNCT05962437
Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia
A study testing Self-guided digital Acceptance and Commitment Therapy, FM symptom tracking app (FM-ST) and Treatment as Usual (TAU) in people with Fibromyalgia, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Self-guided digital Acceptance and Commitment Therapy, FM symptom tracking app (FM-ST) and Treatment as Usual (TAU)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Vall d'Hebrón
Barcelona, Barcelona, 08035
Mayte Serrat, PhD, +34934863000 ext. 3361, mayte.serrat@vallhebron.cat
Mayte Serrat, PhD
- Recruiting
Parc Sanitari Sant Joan de Déu (PSSJD)
Sant Boi de Llobregat, Barcelona, 08830
Juan V Luciano, PhD, +34936406350 ext. 2540, juanvicente.luciano@sjd.es
Antoni Rozadilla-Sacanell, MD, PhD, +34936615208, antoni.rozadilla@sjd.es
About this study
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
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 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.
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.
Read the 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 immune-inflmmatory biomarkers alongside 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, 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 Health System.
- Conditions
- Fibromyalgia
- Being tested
- Self-guided digital Acceptance and Commitment Therapy, FM symptom tracking app (FM-ST), Treatment as Usual (TAU)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided digital Acceptance and Commitment TherapyDevice
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.
FM symptom tracking app (FM-ST)Device
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)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Self-guided digital Acceptance and Commitment Therapy; Behavioral: Treatment as Usual (TAU) |
| 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. Receives: Device: FM symptom tracking app (FM-ST); Behavioral: Treatment as Usual (TAU) |
| Treatment as Usual (TAU) | Active comparator | Usual care is mainly carried out by general practitioners and rheumatologists through regular consultations. Clinicians prescribe medications and provide some counselling. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire Revised (FIQR)
The FIQR includes 21 items that are answered on a 0-10 numerical scale in which higher scores indicate greater functional impairment. The FIQR assesses the impact of FM symptoms over the past 7 days. The questionnaire consists of items that cover three domains: physical impairment, overall impact, and symptom severity. These items inquire about various aspects such as pain, energy levels, stiffness, sleep quality, depression, memory problems, anxiety, sensitivity to touch, balance issues, and heightened sensitivity to noises, lights, smells, or temperatures. The total FIQR score is calculated by summing the scores of the three subscales, resulting in a range of 0 to 100. Higher scores indicate a greater level of impairment. The Spanish version of the FIQR has an excellent internal consistency (α = 0.91-0.95)
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
This instrument is an indicator of meaningful clinical change in treatments for chronic pain. The PGIC is one item (on a 7-point numerical scale, from 1 = 'Much better' to 7 = 'Much worse') referred to the participants' perception of global improvement due to treatment. It has undergone validation in the context of psychologically-based treatments for chronic pain. Additionally, the PSIC evaluates (also on a 7-point Likert scale) changes in specific domains, including physical and social functioning, work-related activities, mood, and pain. Both the PGIC \& PSIC scales will be completed by participants assigned to STANZA and FM-ST treatments.
Measured: At 3 and 6-months follow-up
The Depression Anxiety Stress Scales-21 (DASS-21)
It discriminates between features of depression, anxiety and stress in clinical and non-clinical samples. Responders are required to indicate the presence of several symptoms over the previous week. Each item is scored from 0 (´Did not apply to me at all over the last week') to 3 ('applied to me very much or most of the time over the past week'). There are 7 items on each of the three subscales: depression, anxiety and stress. Therefore, total scores in each scale can range from 0 to 21, with higher scores indicating more severe levels of depression, anxiety and stress. The Spanish version has excellent psychometric properties.
Measured: Through study completion, an average of 6 months
The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
It is a 10-item self-report measure of subjective cognitive dysfunction in FM during the last week. Each item is scored from 1 ('Not at all/Never') to 5 ('Very much/Always') and the total score ranges from 10 to 50. Lower scores indicate higher cognitive dysfunction. The MISCI was developed through classical test theory and item response theory from cognitive functioning item banks developed within the Patient Reported Outcomes Measurement Information System (PROMIS). The Spanish version of the MISCI has excellent internal reliability (α = 0.91)
Measured: Through study completion, an average of 6 months
The Pain Catastrophising Scale (PCS)
Scale of 13 items comprising three dimensions: rumination over pain, magnification of pain and helplessness in the face of pain symptoms. The PCS total score and subscale scores are computed as the sum of ratings for each item.
This study uses the total score, which can vary from 0 to 52 with higher scores indicating greater pain catastrophising.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Swing Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Juan V Luciano, PhD, Principal investigator, Universitat Autònoma de Barcelona (UAB) & FSJD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962437
- Sponsor's protocol ID
- PI22/00829
- Acronym
- SMART-FM-SP
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallego A, Serrat M, Royuela-Colomer E, Sanabria-Mazo JP, Borras X, Esteve M, Grasa M, Rosa A, Rozadilla-Sacanell A, Almirall M, D'Amico F, Dai Y, Rosenbluth MJ, McCracken LM, Navarrete J, Feliu-Soler A, Luciano JV. Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia. Digit Health. 2024 Mar 27;10:20552076241239177. doi: 10.1177/20552076241239177. eCollection 2024 Jan-Dec.
PubMed 38550263
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05962437
- Acronym / sponsor ID
- SMART-FM-SP / PI22/00829
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Swing Therapeutics, Inc.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 immune-inflmmatory biomarkers alongside 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, 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 Health System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STANZA-Spain | Experimental | Device: Self-guided digital Acceptance and Commitment Therapy, Behavioral: Treatment as Usual (TAU)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. |
| FibroST-Spain | Active comparator | Device: FM symptom tracking app (FM-ST), Behavioral: Treatment as Usual (TAU)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. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided digital Acceptance and Commitment TherapySmartphone-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. | Device | STANZA-Spain |
| 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. | Device | FibroST-Spain |
| 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) | Behavioural | FibroST-Spain, STANZA-Spain, Treatment as Usual (TAU) |
Primary outcome
Fibromyalgia Impact Questionnaire Revised (FIQR)
Time frame: Through study completion, an average of 6 months
The FIQR includes 21 items that are answered on a 0-10 numerical scale in which higher scores indicate greater functional impairment. The FIQR assesses the impact of FM symptoms over the past 7 days. The questionnaire consists of items that cover three domains: physical impairment, overall impact, and symptom severity. These items inquire about various aspects such as pain, energy levels, stiffness, sleep quality, depression, memory problems, anxiety, sensitivity to touch, balance issues, and heightened sensitivity to noises, lights, smells, or temperatures. The total FIQR score is calculated by summing the scores of the three subscales, resulting in a range of 0 to 100. Higher scores indicate a greater level of impairment. The Spanish version of the FIQR has an excellent internal consistency (α = 0.91-0.95)
4 secondary outcomes
The Patient Global Impression of Change (PGIC) and the Pain Specific Impression of Change (PSIC)
Time frame: At 3 and 6-months follow-up
The Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Through study completion, an average of 6 months
The Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
Time frame: Through study completion, an average of 6 months
The Pain Catastrophising Scale (PCS)
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 38550263Gallego A, Serrat M, Royuela-Colomer E, Sanabria-Mazo JP, Borras X, Esteve M, Grasa M, Rosa A, Rozadilla-Sacanell A, Almirall M, D'Amico F, Dai Y, Rosenbluth MJ, McCracken LM, Navarrete J, Feliu-Soler A, Luciano JV. Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia. Digit Health. 2024 Mar 27;10:20552076241239177. doi: 10.1177/20552076241239177. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan V Luciano, PhD principal investigator
Universitat Autònoma de Barcelona (UAB) & FSJD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided digital Acceptance and Commitment Therapy, FM symptom tracking app (FM-ST) and Treatment as Usual (TAU) in people with Fibromyalgia, run by Fundació Sant Joan de Déu at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaime Navarrete, PhD (+34936406350 ext. 2543, jaime.navarrete@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire Revised (FIQR) (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.