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

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

Overview

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.

Interventions

• Behavioral FIBROWALK
  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 functionalit
• Behavioral Unified Protocol
  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-sp

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (6)

• 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.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Vall Hebron University Hospital — Barcelona

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. PMID 34499174
• 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
• 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
• 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
• 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.
• 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
• 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

Identifiers

NCT: NCT06906991 · FIBROWALK+UP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗