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NCT06906991 | NOT YET RECRUITING | Fibromyalgia (FM)


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

Vall d'Hebron Research Institute University Hospital

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.

Condition or disease

Fibromyalgia (FM)

Intervention/treatment

FIBROWALK

Unified Protocol

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 182 participants
Masking : SINGLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-05-15
Estimated Primary Completion Date : 2026-02-01
Estimated Study Completion Date : 2026-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).

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

Location Details

NCT06906991


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Locations


Not yet recruiting

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

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