Service User and Staff Views on Digital Remote Monitoring for Psychosis

Sponsor
Manchester Academic Health Science Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05670197
Collaborator
University of Glasgow (Other), University of Edinburgh (Other), King's College London (Other), Cardiff University (Other), University of Sussex (Other)
100
6
14
16.7
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention. Participants will take part in a qualitative interview

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
A Qualitative Study of Service User and Staff Views on Digital Remote Monitoring for Unusual Distressing Experiences (Psychosis)
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Demographics [one hour]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Manchester Manchester Greater Manchester United Kingdom M13 9PL
2 University of Sussex Brighton United Kingdom
3 Cardiff University Cardiff United Kingdom
4 University of Edinburgh Edinburgh United Kingdom
5 University of Glasgow Glasgow United Kingdom
6 King's College London London United Kingdom

Sponsors and Collaborators

  • Manchester Academic Health Science Centre
  • University of Glasgow
  • University of Edinburgh
  • King's College London
  • Cardiff University
  • University of Sussex

Investigators

  • Study Chair: Sandra Bucci, ClinPsyD, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandra Bucci, Professor Sandra Bucci, Manchester Academic Health Science Centre
ClinicalTrials.gov Identifier:
NCT05670197
Other Study ID Numbers:
  • NHS001961
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sandra Bucci, Professor Sandra Bucci, Manchester Academic Health Science Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023