Fibromyalgia (FM)FIBROWALK+UPNCT06906991
Multicomponent FIBROWALK Therapy Plus Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia
A study testing FIBROWALK and Unified Protocol in people with Fibromyalgia (FM), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and cognitive dysfunction. Although the FIBROWALK multicomponent program improves physical functionality and pain, its impact on emotional regulation remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- FIBROWALK and Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2025to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with fibromyalgia, according to the 2011 American College of Rheumatology (ACR) modified criteria.
- Aged 18 or older.
Who cannot join
- Individuals with psychotic disorders, substance abuse, or severe cognitive impairment (based on medical evaluation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Vall Hebron University Hospital
Barcelona, 08035
Miriam Almirall, PhD, +34 617044723, miriam.almirall@vallhebron.cat
About this study
Official title: Psychological Treatment Based on the Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia: What Does It Add to the Multicomponent FIBROWALK Therapy? A Randomized Controlled Trial
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and cognitive dysfunction. Although the FIBROWALK multicomponent program improves physical functionality and pain, its impact on emotional regulation remains limited. This study aims to integrate the Unified Protocol (UP), a cognitive-behavioral therapy (CBT) approach, to enhance emotional and physical distress tolerance in fibromyalgia patients and explore participants' satisfaction, difficulties, and barriers to treatment.
This study investigates the efficacy of integrating the Unified Protocol (UP), a transdiagnostic intervention based on CBT, with the multicomponent FIBROWALK therapy for individuals with fibromyalgia. The trial seeks to enhance emotional regulation, reduce anxiety and depression, and improve quality of life. Additionally, it will gather qualitative feedback from participants to identify challenges, barriers, and potential improvements to the therapeutic intervention.
- Conditions
- Fibromyalgia (FM)
- Being tested
- FIBROWALK, Unified Protocol
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBROWALKBehavioural
FIBROWALK is a structured, multicomponent therapeutic program designed specifically for patients with fibromyalgia, combining evidence-based interventions that target both physical and emotional symptoms of the condition. Unlike traditional standalone interventions (e.g., exercise-only or CBT-only), FIBROWALK integrates multiple therapeutic modalities in a holistic, group-based format to address the broad symptom profile of fibromyalgia, including chronic pain, fatigue, and impaired functionality. Sessions are delivered in groups of up to 20 participants, fostering peer support and shared learning.
Key Components of FIBROWALK:
- Therapeutic Exercise
- Pain Neuroscience Education
- Cognitive-Behavioral Therapy
- Mindfulness-Based Stress Reduction
- Psychoeducation
Unified ProtocolBehavioural
The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy (CBT) intervention designed to address emotional dysregulation across a range of mental health conditions. Unlike traditional disorder-specific CBT interventions (e.g., CBT for anxiety or depression), the UP targets core emotional processes common to multiple disorders, making it particularly suitable for fibromyalgia patients who often experience comorbid anxiety, depression, and emotional distress. Unlike condition-specific therapies, the UP addresses the shared emotional mechanisms underlying anxiety, depression, and chronic pain, making it well-suited for fibromyalgia patients with complex emotional and physical symptomatology. UP emphasizes increasing tolerance to emotional and physical discomfort, a critical area for fibromyalgia patients who often experience heightened emotional reactivity and pain sensitivity.
The UP is delivered individually and consists of 12 structured, manualized modules.
| Study group | Role | What they receive |
|---|---|---|
| FIBROWALK Program | Active comparator | Multicomponent group-based therapy including therapeutic exercise, pain neuroscience education, CBT, and mindfulness.
Delivered over 12 weekly group sessions (2 hours per session). Receives: Behavioral: FIBROWALK |
| FIBROWALK + Unified Protocol (UP) | Experimental | Participants receive the same FIBROWALK intervention, plus the Unified Protocol (UP), a psychological transdiagnostic intervention which will be delivered individually in parallel.
The UP consists of 12 individual sessions (50-60 minutes each), covering modules on emotional awareness, distress tolerance, and reducing avoidance. Receives: Behavioral: FIBROWALK; Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
This scale will measure changes in anxiety and depression levels. HADS is a validated 14-item questionnaire specifically designed to detect anxiety and depression symptoms in patients with chronic health conditions, including fibromyalgia.
Measured: Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up. Changes in anxiety and depression scores from baseline to post-treatment and 6-month follow-up.
Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
This tool will assess the overall impact of fibromyalgia on patients' daily functionality, covering physical limitations, pain intensity, fatigue, and general well-being. Higher scores indicate worse fibromyalgia impact.
Measured: Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up. Changes in functioning scores from baseline to post-treatment and 6-month follow-up.
Secondary outcomes (6)
Frustration Discomfort Scale (FDS)
This questionnaire evaluates participants' tolerance to frustration and emotional distress, which are key targets in the Unified Protocol intervention. It measures responses to challenging emotional and physical experiences.
Measured: Changes in distress tolerance scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Satisfaction with Life Scale (SWLS)
This scale measures participants' subjective well-being and overall life satisfaction. It consists of five items that assess life satisfaction on a 7-point Likert scale.
Measured: Changes in satisfaction with life scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Visual Analog Scales (VAS) for Pain and Fatigue
Self-reported scales ranging from 0 (no pain/fatigue) to 10 (worst possible pain/fatigue) will be used to assess the perceived intensity of pain and fatigue, which are core symptoms of fibromyalgia.
Measured: Changes in pain and fatigue scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Psychological Inflexibility in Pain Scale (PIPS)
This scale measures two key factors in chronic pain patients: cognitive fusion (difficulty detaching from pain-related thoughts) and experiential avoidance (efforts to avoid or control pain-related experiences).
Measured: Changes in psychological inflexibility scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Credibility/Expectancy Questionnaire (CEQ)
This 6-item questionnaire assesses participants' perceived credibility of and expectations for the treatment. It will be administered both at baseline to measure initial expectations and post-treatment to measure changes in perception.
Measured: Changes in perceived credibility of and expectations for the treatment scores from baseline to post-treatment. Administered at baseline and post-treatment (12 weeks).
Blood Neutrophil-Lymphocyte Ratio (NLR)
The neutrophil-lymphocyte ratio (NLR) will be measured as a marker of systemic inflammation. NLR has been associated with inflammatory responses in various chronic conditions, including fibromyalgia. This ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from blood samples collected at each time point.
Measured: Changes in NLR scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Model description
- This is a randomized controlled trial (RCT) with two intervention groups: (1) FIBROWALK only and (2) FIBROWALK + Unified Protocol (UP). Participants will be assessed at baseline (pre-treatment), post-treatment, and at a six-month follow-up. The study will enroll 182 participants with fibromyalgia, based on eligibility criteria set by the Rheumatology Service at Vall d'Hebron Hospital.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906991
- Sponsor's protocol ID
- FIBROWALK+UP
- Acronym
- FIBROWALK+UP
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, the individual participant data (IPD) collected during the study will not be shared publicly due to privacy concerns and the ethical requirements related to handling sensitive health data. The study follows GDPR (General Data Protection Regulation) and Spanish national regulations (LOPD 3/2018) on the protection and confidentiality of personal health information. Although the data will be anonymized and securely stored, sharing IPD outside the research team may not be feasible without additional participant consent and institutional approvals. Requests for data access may be considered on a case-by-case basis and must align with ethical guidelines, institutional policies, and data protection laws.
Publications
Serrat M, Sanabria-Mazo JP, Almirall M, Muste M, Feliu-Soler A, Mendez-Ulrich JL, Sanz A, Luciano JV. Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial. Phys Ther. 2021 Dec 1;101(12):pzab200. doi: 10.1093/ptj/pzab200.
PubMed 34499174Serrat M, Coll-Omana M, Albajes K, Sole S, Almirall M, Luciano JV, Feliu-Soler A. Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain. Int J Environ Res Public Health. 2021 Sep 30;18(19):10300. doi: 10.3390/ijerph181910300.
PubMed 34639600Suso-Ribera C, Camacho-Guerrero L, Osma J, Suso-Vergara S, Gallardo-Pujol D. A Reduction in Pain Intensity Is More Strongly Associated With Improved Physical Functioning in Frustration Tolerant Individuals: A Longitudinal Moderation Study in Chronic Pain Patients. Front Psychol. 2019 Apr 26;10:907. doi: 10.3389/fpsyg.2019.00907. eCollection 2019.
PubMed 31133917Osma J, Martinez-Garcia L, Quilez-Orden A, Peris-Baquero O. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Medical Conditions: A Systematic Review. Int J Environ Res Public Health. 2021 May 11;18(10):5077. doi: 10.3390/ijerph18105077.
PubMed 34064898Barlow, D. H., Farchione, T. J., Sauer-Zavala, S., Latin, H. M., Burris, J. R., Bentley, K. H., Boettcher, H. T., & Cassiello-Robbins, C. (2019). Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta (J. J. Osma López & E. Crespo Delgado, Trads.; Segunda edición revisada y actualizada). Alianza Editorial.
Angarita-Osorio N, Perez-Aranda A, Feliu-Soler A, Andres-Rodriguez L, Borras X, Suso-Ribera C, Slim M, Herrera-Mercadal P, Fernandez-Vergel R, Blanco ME, Luciano JV. Patients With Fibromyalgia Reporting Severe Pain but Low Impact of the Syndrome: Clinical and Pain-Related Cognitive Features. Pain Pract. 2020 Mar;20(3):255-261. doi: 10.1111/papr.12847. Epub 2019 Nov 11.
PubMed 31627253Allen LB, Tsao JCI, Seidman LC, Ehrenreich-May J, Zeltzer LK. A Unified, Transdiagnostic Treatment for Adolescents With Chronic Pain and Comorbid Anxiety and Depression. Cogn Behav Pract. 2012 Feb;19(1):56-67. doi: 10.1016/j.cbpra.2011.04.007.
PubMed 28824271
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment Based on the Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia: What Does It Add to the Multicomponent FIBROWALK Therapy? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06906991
- Acronym / sponsor ID
- FIBROWALK+UP / FIBROWALK+UP
- Conditions
- Fibromyalgia (FM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Apr 2025 (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.
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and cognitive dysfunction. Although the FIBROWALK multicomponent program improves physical functionality and pain, its impact on emotional regulation remains limited. This study aims to integrate the Unified Protocol (UP), a cognitive-behavioral therapy (CBT) approach, to enhance emotional and physical distress tolerance in fibromyalgia patients and explore participants' satisfaction, difficulties, and barriers to treatment.
This study investigates the efficacy of integrating the Unified Protocol (UP), a transdiagnostic intervention based on CBT, with the multicomponent FIBROWALK therapy for individuals with fibromyalgia. The trial seeks to enhance emotional regulation, reduce anxiety and depression, and improve quality of life. Additionally, it will gather qualitative feedback from participants to identify challenges, barriers, and potential improvements to the therapeutic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial (RCT) with two intervention groups: (1) FIBROWALK only and (2) FIBROWALK + Unified Protocol (UP). Participants will be assessed at baseline (pre-treatment), post-treatment, and at a six-month follow-up. The study will enroll 182 participants with fibromyalgia, based on eligibility criteria set by the Rheumatology Service at Vall d'Hebron Hospital.
| Arm | Type | Receives |
|---|---|---|
| FIBROWALK Program | Active comparator | Behavioral: FIBROWALKMulticomponent group-based therapy including therapeutic exercise, pain neuroscience education, CBT, and mindfulness. Delivered over 12 weekly group sessions (2 hours per session). |
| FIBROWALK + Unified Protocol (UP) | Experimental | Behavioral: FIBROWALK, Behavioral: Unified ProtocolParticipants receive the same FIBROWALK intervention, plus the Unified Protocol (UP), a psychological transdiagnostic intervention which will be delivered individually in parallel. The UP consists of 12 individual sessions (50-60 minutes each), covering modules on emotional awareness, distress tolerance, and reducing avoidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults diagnosed with fibromyalgia, according to the 2011 American College of Rheumatology (ACR) modified criteria.
- Aged 18 or older.
Key exclusion criteria (1 listed)
- Individuals with psychotic disorders, substance abuse, or severe cognitive impairment (based on medical evaluation).
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 |
|---|---|---|
| FIBROWALKFIBROWALK is a structured, multicomponent therapeutic program designed specifically for patients with fibromyalgia, combining evidence-based interventions that target both physical and emotional symptoms of the condition. Unlike traditional standalone interventions (e.g., exercise-only or CBT-only), FIBROWALK integrates multiple therapeutic modalities in a holistic, group-based format to address the broad symptom profile of fibromyalgia, including chronic pain, fatigue, and impaired functionality. Sessions are delivered in groups of up to 20 participants, fostering peer support and shared learning. Key Components of FIBROWALK: * Therapeutic Exercise * Pain Neuroscience Education * Cognitive-Behavioral Therapy * Mindfulness-Based Stress Reduction * Psychoeducation | Behavioural | FIBROWALK + Unified Protocol (UP), FIBROWALK Program |
| Unified ProtocolThe Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy (CBT) intervention designed to address emotional dysregulation across a range of mental health conditions. Unlike traditional disorder-specific CBT interventions (e.g., CBT for anxiety or depression), the UP targets core emotional processes common to multiple disorders, making it particularly suitable for fibromyalgia patients who often experience comorbid anxiety, depression, and emotional distress. Unlike condition-specific therapies, the UP addresses the shared emotional mechanisms underlying anxiety, depression, and chronic pain, making it well-suited for fibromyalgia patients with complex emotional and physical symptomatology. UP emphasizes increasing tolerance to emotional and physical discomfort, a critical area for fibromyalgia patients who often experience heightened emotional reactivity and pain sensitivity. The UP is delivered individually and consists of 12 structured, manualized modules. | Behavioural | FIBROWALK + Unified Protocol (UP) |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up. Changes in anxiety and depression scores from baseline to post-treatment and 6-month follow-up.
This scale will measure changes in anxiety and depression levels. HADS is a validated 14-item questionnaire specifically designed to detect anxiety and depression symptoms in patients with chronic health conditions, including fibromyalgia.
Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Time frame: Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up. Changes in functioning scores from baseline to post-treatment and 6-month follow-up.
This tool will assess the overall impact of fibromyalgia on patients' daily functionality, covering physical limitations, pain intensity, fatigue, and general well-being. Higher scores indicate worse fibromyalgia impact.
6 secondary outcomes
Frustration Discomfort Scale (FDS)
Time frame: Changes in distress tolerance scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Satisfaction with Life Scale (SWLS)
Time frame: Changes in satisfaction with life scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Visual Analog Scales (VAS) for Pain and Fatigue
Time frame: Changes in pain and fatigue scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Psychological Inflexibility in Pain Scale (PIPS)
Time frame: Changes in psychological inflexibility scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Changes in perceived credibility of and expectations for the treatment scores from baseline to post-treatment. Administered at baseline and post-treatment (12 weeks).
Blood Neutrophil-Lymphocyte Ratio (NLR)
Time frame: Changes in NLR scores from baseline to post-treatment and 6-month follow-up. Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up.
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 2 Apr 2025.
- Background: PubMed 34499174Serrat M, Sanabria-Mazo JP, Almirall M, Muste M, Feliu-Soler A, Mendez-Ulrich JL, Sanz A, Luciano JV. Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial. Phys Ther. 2021 Dec 1;101(12):pzab200. doi: 10.1093/ptj/pzab200.
- Background: PubMed 34639600Serrat M, Coll-Omana M, Albajes K, Sole S, Almirall M, Luciano JV, Feliu-Soler A. Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain. Int J Environ Res Public Health. 2021 Sep 30;18(19):10300. doi: 10.3390/ijerph181910300.
- Background: PubMed 31133917Suso-Ribera C, Camacho-Guerrero L, Osma J, Suso-Vergara S, Gallardo-Pujol D. A Reduction in Pain Intensity Is More Strongly Associated With Improved Physical Functioning in Frustration Tolerant Individuals: A Longitudinal Moderation Study in Chronic Pain Patients. Front Psychol. 2019 Apr 26;10:907. doi: 10.3389/fpsyg.2019.00907. eCollection 2019.
- Background: PubMed 34064898Osma J, Martinez-Garcia L, Quilez-Orden A, Peris-Baquero O. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Medical Conditions: A Systematic Review. Int J Environ Res Public Health. 2021 May 11;18(10):5077. doi: 10.3390/ijerph18105077.
- BackgroundBarlow, D. H., Farchione, T. J., Sauer-Zavala, S., Latin, H. M., Burris, J. R., Bentley, K. H., Boettcher, H. T., & Cassiello-Robbins, C. (2019). Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta (J. J. Osma López & E. Crespo Delgado, Trads.; Segunda edición revisada y actualizada). Alianza Editorial.
- Background: PubMed 31627253Angarita-Osorio N, Perez-Aranda A, Feliu-Soler A, Andres-Rodriguez L, Borras X, Suso-Ribera C, Slim M, Herrera-Mercadal P, Fernandez-Vergel R, Blanco ME, Luciano JV. Patients With Fibromyalgia Reporting Severe Pain but Low Impact of the Syndrome: Clinical and Pain-Related Cognitive Features. Pain Pract. 2020 Mar;20(3):255-261. doi: 10.1111/papr.12847. Epub 2019 Nov 11.
- Background: PubMed 28824271Allen LB, Tsao JCI, Seidman LC, Ehrenreich-May J, Zeltzer LK. A Unified, Transdiagnostic Treatment for Adolescents With Chronic Pain and Comorbid Anxiety and Depression. Cogn Behav Pract. 2012 Feb;19(1):56-67. doi: 10.1016/j.cbpra.2011.04.007.
- Individual participant dataSharing planned: No. At this time, the individual participant data (IPD) collected during the study will not be shared publicly due to privacy concerns and the ethical requirements related to handling sensitive health data. The study follows GDPR (General Data Protection Regulation) and Spanish national regulations (LOPD 3/2018) on the protection and confidentiality of personal health information. Although the data will be anonymized and securely stored, sharing IPD outside the research team may not be feasible without additional participant consent and institutional approvals. Requests for data access may be considered on a case-by-case basis and must align with ethical guidelines, institutional policies, and data protection laws.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIBROWALK and Unified Protocol in people with Fibromyalgia (FM), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Carlos Suso-Ribera, PhD (+34 670421577, carlos.suso@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: Baseline (pre-treatment), post-treatment (12 weeks), and at 6-month follow-up. Changes in anxiety and depression scores from baseline to post-treatment and 6-month follow-up.). The study lists 2 primary outcomes in all. 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 NCT06906991, which also lists 7 linked publications.
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 2 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.