(PS12-A2) Reduction of Fibromyalgia Severity with a Digital Acceptance and Commitment Therapy

Fibromyalgia (FM) is a chronic pain disorder that is often accompanied by fatigue, sleep problem, and many other symptoms that negatively impact quality of life. The complex and heterogeneous clinical manifestations affect 2-6% of the population, leading to high clinical and economic burden that worsens with greater FM severity. Clinical guidelines recommend multidisciplinary treatment for FM, including non-pharmacological options such as cognitive behavioral therapy (CBT) and exercise. A smartphone-based, 12-week digital therapeutic (FM-ACT) has been developed to deliver self-guided acceptance and commitment therapy, a form of CBT, for the management of FM. This study assessed the effectiveness of FM-ACT in reducing FM severity. An analysis was performed on FM patients who received FM-ACT treatment in 3 clinical trials (2 RCTs, 1 single-arm real-world study). All participants with outcomes data at end of study (week 12) were assessed. Clinical measures were evaluated based on severity level classifications as follows: 1) Revised Fibromyalgia Impact Questionnaire (FIQ-R: “mild”, “moderate”, and “severe” following the original FIQ definition); 2) Sleep and Pain Interference numeric rating scales (severity levels: 0 – “none”, 1-3 – “mild”, 4-7 – “moderate”, 8-10 – “severe”); 3) Beck Depression Inventory II total score (BDI-II, severity levels: “subclinical”, “mild”, “moderate”, “severe” following instrument’s definition); and 4) BDI-II “tiredness and fatigue” item on fatigue interference (severity levels: 0 – “none”, 1 – “mild”, 2 – “moderate”, 3 – “severe”). Baseline to endpoint (week 12) change in severity level on each clinical measure were evaluated for each participant. Responders on a clinical measure were defined as participants who had baseline to endpoint reduction of at least one severity level. Additionally, patients’ Global Impression of Change (PGIC) was assessed at the endpoint to evaluate the reported improvement in an individual’s overall well-being. A total of 143 participants were analyzed. Baseline to endpoint reduction on FIQ-R total score value ranged from 13% (“mild” baseline group) to 24% (“severe” baseline group). FIQ-R responder rates were 39% and 40% in the baseline “moderate” and “severe” groups, respectively. Responders on BDI-II “tiredness and fatigue” item were 36%, 59%, and 72% in the “mild”, “moderate”, and “severe” baseline groups, respectively. Similar responses were observed on the other clinical measures assessed, with reductions in severity level being more prominent in the groups with greater baseline severity. Groups classified as “severe” at baseline showed responder rates of 73% (pain interference), 67% (sleep interference), and 100% (BDI-II total score) at the endpoint. Overall well-being was improved in 72% of participants at the endpoint (PGIC, any improvement). This analysis demonstrates that FM-ACT treatment reduced the level of symptom severity and improved well-being among the FM patients participated in the cohort. The findings have both clinical and economic implications, suggesting that FM-ACT may offer improvement in patient outcomes and lower economic burden as well, driven by the reduced symptom severity in the FM population.