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Completed

NCT Number: NCT05670197

Service User and Staff Views on Digital Remote Monitoring for Psychosis

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Manchester, Manchester, Greater Manchester, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention. Participants will take part in a qualitative interview

Other

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.

Primary outcomes

  1. Service user and staff views on complex digital remote monitoring

    Time frame: 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 outcomes

  1. Demographics

    Time frame: one hour

    Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.

Sponsors and collaborators

Lead sponsor

Manchester Academic Health Science Centre

Other

Collaborators

  • Cardiff University
  • King's College London
  • University of Edinburgh
  • University of Glasgow
  • University of Sussex

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2023
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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