Language & Functional Capacity in patients with Depression & Psychosis
Research type
Research Study
Full title
A longitudinal study in Schizophrenia and Major Depressive Disorder to Explore the Relationship Between Language, Negative Symptoms, Cognitive Performance and Functional Capacity (CALM Study)
IRAS ID
324717
Contact name
Sukhi Shergill
Contact email
Sponsor organisation
Kings College London
Clinicaltrials.gov Identifier
To be confirmed once registered, The Open Science Framework [OSF.io]
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Speech and language production play an important role in the diagnosis and treatment of mental health disorders. Speech and language can sometimes be affected by neurological changes and impairments can have an influence over performance of activities of daily living and social interactions. Previous research has shown there is a relationship between speech patterns and mental health problems, and computerised methods of detecting these changes are being developed. Few studies have looked at the relationship between speech and severity of symptoms and level of functioning, especially over longer periods of time as symptoms and levels of functioning may change. This study aims to help fill these gaps in knowledge, by using current device technology to allow the assessments to be carried out over a longer period of time, away from the clinic.
Executive function (mental skills that include working memory, flexible thinking, and self-control) and cognitive control (the process by which goals or plans influence behaviour) are terms used to describe cognitive processes vital for sustaining attention, monitoring information and selecting behaviours in order to attain a goal. We use these skills every day to learn, work, and manage daily life. Previous research has shown these processes are commonly impaired in people who have a range of psychiatric and neurological disorders however, not much research has focussed on measuring the impairments in more than one disorder at any one time. Many disorders have overlapping symptoms and it is unclear to what extent these reflect impairments in processes which are present in more than one disorder, or if different processes are impaired in different disorders. To help better understand these impairments, this study will look at the differences and similarities in these processes in people with and without Schizophrenia or Major Depressive Disorder. To do this, we have developed a set of 16 online cognitive tasks which assess different cognitive processes. This study will add to data being collected in other studies, to help us to identify which of these tasks or combination of tasks could be used to measure the key aspects relevant to each disorder.
This 3-part study is funded by Boehringer Ingelheim, a pharmaceutical company, and will be run by two sites over approximately 2 years. Part 1: We will recruit 75 participants with major depressive disorder, 50 with schizophrenia and 50 age and gender matched healthy participants who will complete some assessments at home using a tablet device over two days. Part 2: 25 participants from each group (a total of 75 participants) will be invited to the clinic so that we can compare the at-home assessments to tests which are commonly used in clinical practice to assess the same abilities. Part 3: We would like all participants who complete part 2 to take part. We will also invite some who have only completed part 1 so that we have a total of 35 participants from each of the patient groups and 30 healthy controls participants taking part (total of 100 participants). They will complete 2 sets of at-home assessments at 2-week intervals over 8 months.REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0836
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Favourable Opinion