Multicomponent FIBROWALK Therapy Plus Unified Protocol for Emotional Regulation in Individuals With Fibromyalgia (FIBROWALK+UP)

Vall d'Hebron University Hospital (HUVH)

Status: Not yet enrolling

Conditions: Fibromyalgia (FM)

Treatments: Behavioral: FIBROWALK; Behavioral: Unified Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06906991

FIBROWALK+UP

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

FIBROWALK Program

Active Comparator group

Description:

Multicomponent group-based therapy including therapeutic exercise, pain neuroscience education, CBT, and mindfulness. Delivered over 12 weekly group sessions (2 hours per session).

Treatment:

Behavioral: FIBROWALK

FIBROWALK + Unified Protocol (UP)

Experimental group

Description:

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.

Treatment:

Behavioral: Unified Protocol

Behavioral: FIBROWALK