Service User and Staff Views on Digital Remote Monitoring for Psychosis

Schizophrenia Clinical Trial

Official title:

A Qualitative Study of Service User and Staff Views on Digital Remote Monitoring for Unusual Distressing Experiences (Psychosis)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670197
• Other study ID #: NHS001961
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Manchester Academic Health Science Centre
• Contact: Emily Eisner, PhD
• Phone: 0161 306 0430
• Email: emily.eisner[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Psychosis is a severe mental health problem. Symptoms of psychosis include hallucinations (e.g. hearing voices that others cannot hear) and delusions (unusual, often troubling beliefs). People who experience psychosis often have times when their symptoms are relatively stable. At other times, their symptoms may increase and become much more problematic (a 'relapse'). Helping people with psychosis to stay well (preventing relapses) is an important and time-consuming challenge for mental health services.

Smartphones and other digital technologies are now widespread. This offers a solution to help tackle the overwhelming demand on services and to enable people with psychosis to access mental health support when they need it most (e.g. when relapsing). Research shows that people with psychosis are often willing to report their symptoms using a smartphone app. Apps like this can alert health professionals when someone needs extra support, but can be burdensome to use long-term. The investigators want to make a system that is less burdensome and is personalised to users' needs and experiences (a 'complex digital remote monitoring system'). Recent research shows that information gathered routinely by individuals' smartphones (e.g. GPS, step count) might help predict relapses of psychosis. The investigators want to use this method in a complex digital remote monitoring system. First, the investigators need to know what people with psychosis and mental health staff think about this idea.

The investigators will interview around sixty adults with psychosis and around forty staff, recruited from UK mental health services (Manchester, Glasgow, Edinburgh, Cardiff, London, Sussex). These one-off, audio-recorded interviews will last up to 60 minutes. The interviewer will ask about participants' views on complex digital remote monitoring. The investigators will then systematically analyse the interviews. Findings will inform the design of the investigators' own complex digital remote monitoring system and future digital tools designed by other researchers. NIHR and Wellcome are funding this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

SERVICE USER PARTICIPANTS

Inclusion Criteria:

• Clinical diagnosis of schizophrenia spectrum disorder (ICD10 F20-29) OR meets the early Intervention for Psychosis Service entry criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States (CAARMS).

• In contact with mental health services

• Over 16 years of age

• Ability to give informed consent

Exclusion Criteria:

• Not sufficiently stable to take part in an interview

• Not sufficiently fluent in English to take part in an interview

STAFF PARTICIPANTS

Inclusion Criteria:

• Work within an adult NHS service providing mental health support to people who experience psychosis / severe mental health problems

• Ability to give informed consent

Exclusion Criteria:

• Not sufficiently fluent in English to take part in an interview

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• No intervention. Participants will take part in a qualitative interview
No intervention. Participants will take part in a one-off, audio-recorded qualitative interview, lasting up to 60 minutes. The interviewer will ask about participants' views on complex digital remote monitoring.

Locations

Country	Name	City	State
United Kingdom	University of Sussex	Brighton
United Kingdom	Cardiff University	Cardiff
United Kingdom	University of Edinburgh	Edinburgh
United Kingdom	University of Glasgow	Glasgow
United Kingdom	King's College London	London
United Kingdom	University of Manchester	Manchester	Greater Manchester

Sponsors (6)

Lead Sponsor	Collaborator
Manchester Academic Health Science Centre	Cardiff University, King's College London, University of Edinburgh, University of Glasgow, University of Sussex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Service user and staff views on complex digital remote monitoring	Qualitative interviews will explore service users' and mental health staff members' views about using smartphones or wearable devices to manage mental health. In particular, we will seek their views about the use of 'complex digital remote monitoring' systems*. The interview will follow a detailed topic guide.; *Complex digital remote monitoring systems in this context include a combination of active symptom monitoring, passive sensing technology, contextual data (GPS location/accelerometer) and/or machine learning algorithms.	one hour
Secondary	Demographics	Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.	one hour