(PS12-A3) Effectiveness of a Digital Acceptance and Commitment Therapy on Fatigue and Sleep Quality in Fibromyalgia: An Appraisal of Clinical Studies

Fatigue and sleep interference are among the most common and disabling symptoms associated with fibromyalgia (FM) and can negatively impacts patients’ lives. A smartphone based digital application has been developed to deliver acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), to treat FM. Several clinical studies have demonstrated the effectiveness of this application (FM-ACT) in reducing FM symptom severity and improving overall well-being. This study reports additional results from an assessment of the effect of FM-ACT on FM-related fatigue and sleep quality. An analysis was performed on FM patients who received 12 weeks of FM-ACT treatment in 3 clinical trials (2 RCTs, 1 single-arm real-world study). Participants with endpoint data collected at week 12 were included in the assessment. Clinical measures evaluated included the BDI-II “tiredness and fatigue” item (measures fatigue interference, with ratings from 0-“none” to 3-“severe”), PROMIS Fatigue T-score, and Sleep Interference (ratings from 0-“no interference” to 10-“completely interfered”). The endpoint outcomes were compared to baseline. A total of 143 participants were analyzed. At endpoint (week 12), 52% (68 out of 131) of those who had fatigue interference at baseline (BDI-II “tiredness and fatigue” > 0) reported improvements of at least one point on the measure. Out of all participants, the proportion of those who reported “moderate” or “severe” fatigue interference (according to BDI-II “tiredness and fatigue” item) decreased from 46% at the baseline to 22% at endpoint. PROMIS Fatigue T-scores were reported from the 2 RCTs. The average improvements aligned with or exceeded the published minimal important change (RCT 1: 2.8 points, RCT 2: 3.1 points). Furthermore, in both RCTs, significant baseline-to-endpoint improvement on PROMIS Fatigue T-score was only observed in the FM-ACT arm (p values < 0.02), not in the control arm. Sixty eight percent of the participants improved at least one point on sleep interference. At the end of the treatment, a higher percentage of participants reported “no” or “mild” sleep interference at endpoint (30%) compared to baseline (7%). This analysis revealed clinically meaningful reduction in fatigue and sleep interference in FM patients who completed FM-ACT treatment. The observed benefit from FM-ACT may be grounded in ACT’s mechanism of action, as it emphasizes mindful acceptance of the present moment, including internal experiences such as fatigue and sleeplessness, and engagement in activities aligned with personal values. These findings align with published studies on the benefit of ACT in improving fatigue symptoms associated with other chronic pain disorders. This preliminary evidence supports that FM-ACT may improve outcomes for fatigue and sleep problems associated with FM.