TrueBlue Clinical Study
Research type
Research Study
Full title
TrueBlue Clinical Study - Investigating the use of a mobile phone app TrueBlue for monitoring Depression and Anxiety
IRAS ID
295721
Contact name
Neil Nixon
Contact email
Sponsor organisation
BlueSkeye AI
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Mental health conditions like depression and anxiety are now the 1st and 6th leading causes of morbidity in the world (WHO,2017). It has been estimated that in the U.K. only one in three people with a clinical case level of depression seek treatment in any given 12 months’ period. Current methods for the diagnosis of such conditions are not only subjective, costly, difficult to repeat but also extremely time consuming. Therefore, it is advantageous to develop new methods which are more objective and require little human intervention.
Motivated by previous results on automatic detection of depression from visual (face) and audio (voice) data, a mobile phone based app “TrueBlue” has been developed which allows users to perform a number of specifically designed tasks. The data collected from the user while completing these tasks (including facial video and audio) is used to predict the user’s depression and anxiety level.
The proposed study will assess the safety, feasibility and acceptability of TrueBlue in the adult population consisting of women in the perinatal period. In addition, it will also involve the development of predictive models, using the user’s behaviour information extracted from audio-visual data to predict commonly used clinical measures of depression, anxiety and anhedonia. The model performance and relationships between model predictions and observed clinical scores will also be explored as a part of this study. To this end, adult women within the perinatal period will be assessed whilst using TrueBlue for up to 16 weeks. The data collected during this study will include: audio, and facial video; self-completion scales; clinician rated scales; and a semi-structured interview for thematic analysis. Focus group activities and qualitative study data will inform iterative app design, consistent with User-Centered Design principles; and will inform the place of TrueBlue within clinical treatment pathways, including those involving Perinatal Psychiatry.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0009
Date of REC Opinion
20 Apr 2022
REC opinion
Further Information Favourable Opinion