UCB & ThinkNinja Digital Therapeutics Project
Research type
Research Study
Full title
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
IRAS ID
288576
Contact name
Frank Burbach
Contact email
Sponsor organisation
Healios LTD
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
In this exploratory randomised controlled trial, we will evaluate the clinical effectiveness & benefits of the ThinkNinja for Epilepsy smartphone app as a supportive tool for people with epilepsy. The app was developed & co-produced by experts with clinical expertise in psychological therapy & digital delivery. It is a self-help conversational virtual assistant built on CBT principles. It provides psychoeducation on epilepsy, staying mentally & emotionally well, CBT techniques for anxiety & low mood symptoms, & an ability to track epileptic seizures. The user is guided by a “Wise Ninja” virtual avatar, who assists with the navigation of the app, & who is able to determine when a user requires additional support. In addition, there is a crisis support feature signposting users to emergency telephone numbers. The app has the ability for the user to access further clinical support with a trained clinician via two step-up clinical intervention levels; step-up level 1 is a text-based asynchronous intervention, & step-up level 2 is a live video-based intervention.
The study aims to enroll 184 adult participants, with clinical levels of anxiety or comorbid anxiety & depression, who have an existing diagnosis of epilepsy. The study will randomly assign participants to one of two conditions – half will receive full access to the ThinkNinja app for 8 weeks, whilst the waiting list control will receive access to the app after 8 weeks.
Online questionnaires will be completed at baseline, after 4 weeks, 8 weeks, & again at 8 weeks post-study (T3) to collect data regarding participant’s self-reported quality of life, global impression of change & medication adherence. Participant anxiety & depression scores will be captured weekly whilst in the active ThinkNinja arm. Post-study, further participant qualitative feedback on the usage & user experience of ThinkNinja will be obtained through 2-3 focus groups (n=4-8 per group).REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0128
Date of REC Opinion
19 Jul 2021
REC opinion
Further Information Favourable Opinion