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

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia (FM)

• Registration Number: NCT06906991
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-05-15
• Primary Completion: 2026-02-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	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.	This scale will measure changes in anxiety and depression levels. HADS is a validated 14-item questionnaire specifically designed to detect anxiety and depression symptoms in patients with chronic health conditions, including fibromyalgia.
Fibromyalgia Impact Questionnaire - Revised (FIQ-R)	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.	This tool will assess the overall impact of fibromyalgia on patients' daily functionality, covering physical limitations, pain intensity, fatigue, and general well-being. Higher scores indicate worse fibromyalgia impact.

Secondary Outcome Measures

Name	Time	Method
Psychological Inflexibility in Pain Scale (PIPS)	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.	This scale measures two key factors in chronic pain patients: cognitive fusion (difficulty detaching from pain-related thoughts) and experiential avoidance (efforts to avoid or control pain-related experiences).
Credibility/Expectancy Questionnaire (CEQ)	Changes in perceived credibility of and expectations for the treatment scores from baseline to post-treatment. Administered at baseline and post-treatment (12 weeks).	This 6-item questionnaire assesses participants' perceived credibility of and expectations for the treatment. It will be administered both at baseline to measure initial expectations and post-treatment to measure changes in perception.
Blood Neutrophil-Lymphocyte Ratio (NLR)	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.	The neutrophil-lymphocyte ratio (NLR) will be measured as a marker of systemic inflammation. NLR has been associated with inflammatory responses in various chronic conditions, including fibromyalgia. This ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count from blood samples collected at each time point.
Visual Analog Scales (VAS) for Pain and Fatigue	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.	Self-reported scales ranging from 0 (no pain/fatigue) to 10 (worst possible pain/fatigue) will be used to assess the perceived intensity of pain and fatigue, which are core symptoms of fibromyalgia.
Frustration Discomfort Scale (FDS)	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.	This questionnaire evaluates participants' tolerance to frustration and emotional distress, which are key targets in the Unified Protocol intervention. It measures responses to challenging emotional and physical experiences.
Satisfaction with Life Scale (SWLS)	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.	This scale measures participants' subjective well-being and overall life satisfaction. It consists of five items that assess life satisfaction on a 7-point Likert scale.

Trial Locations

Locations (1)

Vall Hebron University Hospital; 🇪🇸 Barcelona, Spain