Introduction: Fibromyalgia (FM) is a chronic condition marked by widespread pain, fatigue, sleep disturbances, and cognitive difficulties that significantly impact quality of life. Multiple studies have demonstrated that Acceptance and Commitment Therapy (ACT) alleviates core FM symptoms, but implementation is limited by the availability of qualified therapists.
An FDA-cleared digital ACT program (Stanza™) bridges this gap by delivering self-guided ACT for FM. Two RCTs have demonstrated digital ACT’s efficacy in reducing symptoms of FM.1,2 A real-world study (REACT-FM) also reported significant benefits of digital ACT over 12 weeks.3 The REACT-FM Extension Study reported here followed these participants for 12 months to assess long-term efficacy of digital ACT.
Methods: REACT-FM participants who completed the trial and met eligibility criteria were enrolled in the extension study. Participants retained access to digital ACT and used it at their discretion, with follow-up extending to 12 months from treatment start. Outcomes at 12 months were compared to baseline and outcomes at 12 weeks. Measures included Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire-Revised (FIQ-R), pain intensity & interference and sleep interference (0-10 NRS), depression (BDI-II), pain acceptance (CPAQ-8), and quality of life (WHO-QoL).
Results: 41 participants were enrolled in the extension study. The response rate on the primary outcome measure (minimally improved or better on PGIC) remained stable from week 12 (80.6%) to month 12 (80.0%). The average FIQ-R improvement was 32.1% (SE 4.0%) at 12 weeks and 29.7% (SE 4.7%) at 12 months (p<.0001 at both timepoints). Other symptom improvements significant at 12 weeks maintained significance at 12 months, including the symptom, function, and impact domains of FIQ-R, pain intensity & interference, sleep interference, BDI-II, CPAQ-8, and satisfaction with quality of life.
Discussion: The extension study demonstrated the long-term efficacy of digital ACT in improving symptoms and quality of life for FM patients. The stable proportion of participants reporting improved PGIC from week 12 to month 12 underscores the durability of therapeutic effects. These findings support digital ACT as an effective, accessible, and durable non-drug intervention for FM.
1 Catella et al., J Behav Med 2024; 47: 27-42
2. Gendreau et al., The Lancet 2024; 404: 364074
3. Dai et al., Arthritis & Rheum 2022; 74 (suppl 9): 4439-41