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NOT YET RECRUITING
NCT06906991
NA

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

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2025-05-15

Completion Date

2026-06-01

Last Updated

2025-04-02

Healthy Volunteers

No

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 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

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-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.

Locations (1)

Vall Hebron University Hospital

Barcelona, Spain