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

NANot yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

February 1, 2026

Study Completion Date

June 1, 2026

Conditions
Fibromyalgia (FM)
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."

Trial Locations (1)

08035

Vall Hebron University Hospital, Barcelona

All Listed Sponsors
lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER

NCT06906991 - Multicomponent FIBROWALK Therapy Plus Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia | Biotech Hunter | Biotech Hunter