Service User and Staff Views on Digital Remote Monitoring for Psychosis

December 20, 2022 updated by: Sandra Bucci, Manchester Academic Health Science Centre

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Brighton, United Kingdom
      • Cardiff, United Kingdom
        • Not yet recruiting
        • Cardiff University
        • Contact:
          • James Walters
      • Edinburgh, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • King's College London
        • Contact:
          • Til Wykes
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9PL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
one hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

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 (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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