Clinical trial NCT05670197: Service User and Staff Views on Digital Remote Monitoring for Psychosis
Official title: A Qualitative Study of Service User and Staff Views on Digital Remote Monitoring for Unusual Distressing Experiences (psychosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Schizophrenia
Schizoaffective Disorder
Keywords: smartphone app
wearable
digital health tool
symptom monitoring
passive sensing
mental health
SMI
severe mental health problems
Lead sponsor: Manchester Academic Health Science Centre
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University of Edinburgh
name: King's College London
name: Cardiff University
name: University of Sussex
First posted: 2023-01-04
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Service user and staff views on complex digital remote monitoring
timeFrame: one hour
Secondary outcomes:
measure: Demographics
timeFrame: one hour
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
city: Brighton
country: United Kingdom
facility: University of Sussex
city: Cardiff
country: United Kingdom
facility: Cardiff University
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: University of Manchester
name: Sandra Bucci, ClinPsyD
role: STUDY_CHAIR
References: