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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Hospital Anxiety and Depression Scale (HADS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
FIBROWALK Program
Multicomponent group-based therapy including therapeutic exercise, pain neuroscience education, CBT, and mindfulness.
Delivered over 12 weekly group sessions (2 hours per session).
Intervention: FIBROWALK (Behavioral)
FIBROWALK + Unified Protocol (UP)
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.
Intervention: FIBROWALK (Behavioral)
FIBROWALK + Unified Protocol (UP)
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.
Intervention: Unified Protocol (Behavioral)
Outcomes
Primary Outcomes
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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)
Time Frame: 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 Outcomes
- 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).)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)