NCT05670197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

September 12, 2022

Last Update Submit

November 11, 2024

Conditions

Keywords

smartphone appwearabledigital health toolsymptom monitoringpassive sensingmental healthSMIsevere mental health problems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Demographics

    one hour

Study Arms (2)

Service users

Service users with experience of schizophrenia spectrum psychosis

Other: No intervention. Participants will take part in a qualitative interview

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

Interventions

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 staffService users

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Not sufficiently stable to take part in an interview
  • Not sufficiently fluent in English to take part in an interview
  • STAFF PARTICIPANTS
  • Work within an adult NHS service providing mental health support to people who experience psychosis / severe mental health problems
  • Ability to give informed consent
  • \- Not sufficiently fluent in English to take part in an interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

University of Sussex

Brighton, United Kingdom

Location

Cardiff University

Cardiff, United Kingdom

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaPsychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Sandra Bucci, ClinPsyD

    University of Manchester

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Sandra Bucci

Study Record Dates

First Submitted

September 12, 2022

First Posted

January 4, 2023

Study Start

November 1, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

November 13, 2024

Record last verified: 2024-02

Locations