Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 13, 2022
Open Peer Review Period: Jun 13, 2022 - Aug 8, 2022
Date Accepted: Sep 29, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A randomised controlled trial of a conversational virtual avatar-led cognitive behavioural therapy app intervention for improving the quality of life and mental health of people with epilepsy.
ABSTRACT
Background:
Epilepsy is a common neurological disorder affecting about 1 in 100 people in the UK. 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 while 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 improve their quality of life.
Objective:
In this exploratory randomised controlled trial (RCT), we will evaluate whether an 8-week cognitive behavioural therapy (CBT)-based intervention delivered through a mobile app, ThinkNinja for epilepsy, is a clinically efficacious and effective tool to improve the quality of life, mental health and emotional wellbeing in a large sample of people with epilepsy and anxiety or co-morbid anxiety and depression.
Methods:
The study aims to recruit 184 individuals between 18 - 65 years of age with a self-reported diagnosis of epilepsy and anxiety, or comorbid anxiety and depression. Participants will be randomly assigned to either the ThinkNinja for epilepsy app condition (Arm A) or the waiting list control group (Arm B). Participants assigned to Arm A will receive access to ThinkNinja for epilepsy app first. The waiting list control group (Arm B) will receive the same full access to the ThinkNinja for epilepsy app as the participants in condition A after 8 weeks. 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 (QOLIE-10-P) while the secondary outcomes include measures of anxiety (GAD-7), depression (PHQ-9), medication adherence (MAQ) and impression of change (PGIC).
Results:
The recruitment of this study began in March 2022 and will run until October 2022.
Conclusions:
This study aims to determine the clinical efficacy, effectiveness and safety of ThinkNinja for epilepsy at improving the quality of life, mental health and emotional wellbeing 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 wellbeing support for people with epilepsy. Clinical Trial: ISRCTN 16270209 (04/03/2022)
Citation
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Copyright
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