Service User and Staff Views on Digital Remote Monitoring for Psychosis

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis
• Intervention / Treatment: Other: No intervention. Participants will take part in a qualitative interview

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom
    • University of Sussex
  • Cardiff, United Kingdom
    • Cardiff University
  • Edinburgh, United Kingdom
    • University of Edinburgh
  • Glasgow, United Kingdom
    • University of Glasgow
  • London, United Kingdom
    • King's College London
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9PL
      • University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are drawn from two populations: people with lived experience of schizophrenia spectrum psychosis who are in contact with secondary care mental health services and mental health staff who work in such services. Participants from both groups will be recruited from secondary care mental health services in six geographical locations: Manchester, Glasgow, Edinburgh, Cardiff, Sussex and London.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Service users; Service users with experience of schizophrenia spectrum psychosis	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.
Mental health staff; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.	one hour

Collaborators and Investigators

• Sponsor: Manchester Academic Health Science Centre
• Collaborators: King's College London; Cardiff University; University of Edinburgh; University of Glasgow; University of Sussex
• Investigators: Study Chair: Sandra Bucci, ClinPsyD, University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mental health; wearable; smartphone app; SMI; digital health tool; symptom monitoring; passive sensing; severe mental health problems
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: NHS001961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

We will obtain opt in consent from participants to share their data with other researchers for secondary analysis in future related research studies. Participants will be fully informed of this before consenting. The de-identified dataset will be stored on a secure server at the University of Manchester for up to 20 years and then destroyed.

Researchers wishing to use the data for secondary analysis will be required to make a formal request to the study publication committee and chief investigator, including a statement of the specific research question they wish to address. In all cases, access will be given at the CI and publication committee's discretion. Approved researchers will be furnished with the de-identified dataset by the CI (or delegated individual). Files will be securely transferred to the approved researcher, who will sign a written agreement stating that they will not share the dataset with others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No