Multicomponent FIBROWALK Therapy Plus Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia

NCT06906991 | Not Yet Recruiting DMC

• 1 other identifier: FIBROWALK+UP
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  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

  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)

  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)

  Changes in perceived credibility of and expectations for the treatment scores from baseline to post-treatment. Administered at baseline and post-treatment (12 weeks).

Study Arms (2)

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).

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.

Behavioral: FIBROWALK; Behavioral: Unified Protocol

Interventions

FIBROWALK BEHAVIORAL

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

FIBROWALK + Unified Protocol (UP); FIBROWALK Program

Unified Protocol BEHAVIORAL

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.

FIBROWALK + Unified Protocol (UP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults diagnosed with fibromyalgia, according to the 2011 American College of Rheumatology (ACR) modified criteria.
• Aged 18 or older.

You may not qualify if:

• Individuals with psychotic disorders, substance abuse, or severe cognitive impairment (based on medical evaluation).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall Hebron University Hospital

Barcelona, 08035, Spain

Location

Related Publications (7)

• 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.

  PMID: 34499174 BACKGROUND

• Serrat 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.

  PMID: 34639600 BACKGROUND

• Suso-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.

  PMID: 31133917 BACKGROUND

• Osma 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.

  PMID: 34064898 BACKGROUND

• Barlow, 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

• 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.

  PMID: 31627253 BACKGROUND

• Allen 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.

  PMID: 28824271 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Carlos Suso-Ribera, PhD

CONTACT

+34 670421577; carlos.suso@vallhebron.cat

Mayte Serrat, PhD

CONTACT

+34 616981101; mayte.serrat@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 15, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)