Service User and Staff Views on Digital Remote Monitoring for Psychosis

Completed

• Conditions: Schizoaffective Disorder; Psychosis; Schizophrenia
• Interventions: Other: No intervention. Participants will take part in a qualitative interview

• Registration Number: NCT05670197
• Lead Sponsor: Manchester Academic Health Science Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study Start: 2022-11-01
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2023-01-04
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mental health staff	No intervention. Participants will take part in a qualitative interview	Mental health staff who work within an adult NHS service providing mental health support to people who experience schizophrenia spectrum psychosis / severe mental health problems
Service users	No intervention. Participants will take part in a qualitative interview	Service users with experience of schizophrenia spectrum psychosis

Primary Outcome Measures

Name	Time	Method
Service user and staff views on complex digital remote monitoring	one hour	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.

Secondary Outcome Measures

Name	Time	Method
Demographics	one hour	Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.

Trial Locations

Locations (6)

University of Manchester; 🇬🇧 Manchester, Greater Manchester, 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