Randomized Trial of a Spanish Digital Therapy App STANZA Using Acceptance and Commitment Therapy for Treating Fibromyalgia Comparing Digital Therapy, Symptom Tracking, and Usual Care in Adults

What this Trial Is About

Fibromyalgia is a common syndrome that currently has no cure and results in significant healthcare and societal costs. Researchers are investigating the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention called STANZA-Spain, which is based on Acceptance and Commitment Therapy ACT for adults diagnosed with fibromyalgia. This trial is a six-month, three-arm randomized controlled study recruiting 360 adults who meet the 2016 American College of Rheumatology criteria for fibromyalgia. Participants will be randomly assigned to one of three groups Treatment as usual TAU plus the STANZA digital ACT app, TAU plus a digital symptom tracking app called FibroST, or TAU alone. The STANZA app offers 41 structured ACT lessons designed to be completed in 8 weeks, followed by 4 weeks of maintenance. FibroST provides daily symptom tracking and educational materials without psychotherapy. TAU involves usual care by general practitioners and specialists, including consultations, advice, and medications. Throughout the study, participants will be assessed at baseline, after treatment, and at 6 months follow-up. Assessments include functional impairment using the Fibromyalgia Impact Questionnaire Revised FIQR, patient impressions of change, measures of depression, anxiety, stress, cognitive impairment, and pain catastrophizing. Immune-inflammatory biomarkers will be collected at baseline and post-treatment in a subset of participants. Researchers will also conduct a qualitative analysis to better understand user experiences with the STANZA app. The total study duration for participants is six months.

Self-guided Acceptance and Commitment Therapy-based Digital Smartphone Application for Management of Fibromyalgia