A Conversational, Virtual, Avatar-Led Cognitive Behavioral Therapy App Intervention for Improving the Quality of Life and Mental Health of People With Epilepsy: Protocol for a Randomized Controlled Trial
Authors: Burbach Frank , Lecce Francesca , Allen Victoria M E , Porter Catherine M 
Published: September 2022

Background
Epilepsy is a common neurological disorder affecting about 1 in 100 people in the United Kingdom. Many individuals experience a lower quality of life as a result of their epilepsy diagnosis and are more likely to develop mental health problems, such as anxiety and depression. Medical interventions for this client group tend to focus on the treatment of seizures, whereas mental health disorders often remain undiagnosed and untreated. Early identification and treatment of mental health difficulties in people with epilepsy are vital to ensure better outcomes and improvements in quality of life.

Objective
The aim of this exploratory randomized controlled trial is to evaluate whether an 8-week cognitive behavioral therapy–based intervention delivered through a mobile app—ThinkNinja for Epilepsy—is a clinically effective tool to improve quality of life, mental health, and emotional well-being in a large sample of people with epilepsy and anxiety or comorbid anxiety and depression.

Methods
The study aims to recruit 184 individuals, 18 to 65 years of age, with a self-reported diagnosis of epilepsy and anxiety or comorbid anxiety and depression. Participants will be randomly assigned to the ThinkNinja for Epilepsy app condition (arm A) or the waiting-list control group (arm B). Participants in arm A will receive access to the ThinkNinja for Epilepsy app first. After 8 weeks, participants in arm B will receive the same full access to the ThinkNinja for Epilepsy app as the participants in arm A. This design will allow an initial between-subjects analysis between the two conditions as well as a within-subject analysis including all participants. The primary outcome is participants’ quality of life, measured by the 10-item patient-weighted Quality of Life in Epilepsy questionnaire. The secondary outcomes include measures of anxiety, using the 7-item Generalized Anxiety Disorder assessment; depression, using the 9-item Patient Health Questionnaire; medication adherence, using the Medication Adherence Questionnaire; and impression of change, using the Patient Global Impression of Change questionnaire.

Results
Recruitment for this study began in March 2022 and was completed in October 2022. We expect data collection to be finalized by May 2023 and study results to be available within 12 months of the final data collection date. Results of the study will be written up as soon as possible thereafter, with the intention of publishing the outcomes in high-quality peer-reviewed journals.

Conclusions
This study aims to determine the clinical efficacy and safety of the ThinkNinja for Epilepsy intervention at improving the quality of life, mental health, and emotional well-being of people with epilepsy. The findings from our study will hopefully contribute to addressing the critical gap in universal provision and accessibility of mental health and emotional well-being support for people with epilepsy.

Trial Registration
ISRCTN Registry 16270209 (04/03/2022); https://www.isrctn.com/ISRCTN16270209

International Registered Report Identifier (IRRID)
DERR1-10.2196/40261