Fibromyalgia (FM)
Conditions
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.
Interventions
BEHAVIORALFIBROWALK
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
BEHAVIORALUnified 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.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a randomized controlled trial (RCT) with two intervention groups: (1) FIBROWALK only and (2) FIBROWALK + Unified Protocol (UP). Participants will be assessed at baseline (pre-treatment), post-treatment, and at a six-month follow-up. The study will enroll 182 participants with fibromyalgia, based on eligibility criteria set by the Rheumatology Service at Vall d'Hebron Hospital.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactCarlos Suso-Ribera, PhD
Backup ContactMayte Serrat, PhD
Outcome results
None listed