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Abstract Objective Despite the availability of pharmacological treatment for seizures, people with epilepsy (PwE) commonly experience impairments in quality of life (QoL). Given the limited access to psychosocial treatments for PwE, digital interventions could bridge treatment gaps and help improve QoL. The objective of this study was to examine the effectiveness of emyna, a fully automated digital intervention based on cognitive behavioral therapy (CBT) techniques, in improving health‐related QoL among PwE who reported impairments in QoL. A previous trial showed that emyna was effective in improving depressive symptoms among PwE with a comorbid depressive disorder, but its effects on QoL among PwE without comorbid depression remain unknown. Methods A pragmatic randomized controlled trial was conducted with N = 438 PwE (mean age = 37.5, 70.3% women, physician‐verified diagnoses) who were assigned to the intervention group (n = 216), which used emyna alongside treatment as usual (TAU), or the control group (n = 222), which received TAU only. QoL and secondary outcomes such as general self‐efficacy, medication adherence, general distress, and epilepsy‐related work and social adjustment were assessed at baseline, 3 months, and 6 months. The primary outcome was QoL assessed with the Quality of Life in Epilepsy [QOLIE‐31] total score at 3 months post‐randomization. Results Findings from the intent‐to‐treat analyses showed that after 3 months, participants in the intervention group experienced significant and clinically relevant improvements in health‐related QoL compared to the control group (baseline‐adjusted group difference = 4.5; 95% CI = [2.0, 6.9], p |
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