Cognitive and Mood Assessment Study Using Digital Wearable Technology
Research type
Research Study
Full title
A Single Center Pilot Study to Evaluate Real Time Passive and Active High-Frequency Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology
IRAS ID
220639
Contact name
Maggie McCue
Contact email
Sponsor organisation
Takeda Pharmaceuticals U.S.A., Inc
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The purpose of this study is to assess the validity of daily cognitive and mood assessments on a wearable device, and to understand people’s motivation and ability to complete these assessments. Deficits in cognition are a core symptom of depression. They can contribute to work-related disability and adverse psychosocial outcomes. Currently, cognition in depression is measured through self-reporting and infrequent standardized cognitive tests. These two methods don’t always correspond, and difficulties in accessing cognitive assessment mean that cognitive dysfunction is under-recognised and under-treated. Our goal is to develop a cognitive assessment method that can be used in future research studies with people with depression, and to ultimately improve the detection of cognitive symptoms, treatment engagement and clinician decision-making.
Thirty people aged between 18 and 65 years with mild-moderate depression will be recruited. Participants will be given an Apple Watch, and invited to use an app with brief cognitive and mood tests for them to complete every day for 6 weeks. The study will start with a visit to the study site where participants will be given the Apple Watch and take part in an initial interview. Six weeks later, a researcher will visit each participant at their home for the return of the watch and an end of study interview. The aim of these interviews is to understand how participants are using the device and what, if any, the obstacles were to compliance with testing. At the beginning, middle (week three) and end of the study participants complete web-based cognition and mood assessments, against which scores obtained on the Apple Watch will be compared. These data will be analysed to evaluate whether these novel assessments are scientifically valid, if they can be used in everyday life, and what factors might contribute to people’s motivation and ability to take part.REC name
Wales REC 6
REC reference
17/WA/0042
Date of REC Opinion
17 Feb 2017
REC opinion
Further Information Favourable Opinion