Cognitive and behavioural biomarkers in mental health therapy
Research type
Research Study
Full title
Cognitive and behavioural biomarkers for the treatment of mental health conditions: an investigation of acceptability and efficacy when used as a therapeutic tool
IRAS ID
281261
Contact name
Ana Catarino
Contact email
Sponsor organisation
Ieso Digital Health Ltd
ISRCTN Number
ISRCTN11004397
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Mental health disorders constitute an enormous healthcare concern, with one in four people estimated to be affected. The global economic cost of mental illness is estimated at £105bn per annum in the UK alone. However, access to care remains poor across the globe, and clinical outcomes have remained stagnant for decades. The current study aims to collect and explore the potential value of digital cognitive and behavioural biomarkers in increasing the therapeutic benefits of internet-enabled cognitive behavioural therapy (IECBT). Examples of these cognitive and behavioural biomarkers include features of patient language, summary measures of patients’ physical activity, geolocation, and patterns of social media use and digital interaction.
The project is defined by the following objectives:
• Define a range of cognitive and behavioural biomarkers and explore associations with symptoms of common mental health disorders;
• Assess the acceptability of collection of cognitive and behavioural biomarkers and how willing patients are to volunteer this information within a therapeutic context;
• Develop digital mental health monitoring tools to be used by both patients and therapists;
• Evaluate the effectiveness of digital mental health monitoring tools in providing additional patient information to the therapists, allowing them to personalize treatment protocols with the aim of optimizing clinical outcomes.
The study consists of a randomised controlled trial of patients receiving IECBT for the treatment of a mental health disorder. At the start of treatment consenting patients will be given an activity tracker (Fitbit) and access to a mobile app, allowing them to track behavioural biomarkers against mood. Patients will be randomised to one of two groups:
Therapist and patient visibility: Therapists delivering therapy will also have access to patients’ biomarkers and use this information to tailor the care delivered to each patient and monitor patient outcomes.
Patient visibility only: Therapists will not have access to patients’ biomarker data.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0128
Date of REC Opinion
22 Jun 2020
REC opinion
Further Information Favourable Opinion