PsychosisNCT05670197
Service User and Staff Views on Digital Remote Monitoring for Psychosis
An observational study of Psychosis and Schizophrenia, run by Manchester Academic Health Science Centre at 6 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychosis, Schizophrenia, Schizoaffective Disorder
- How many people
- 118 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 1 Nov 2022to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- Work within an adult NHS service providing mental health support to people who experience psychosis / severe mental health problems
- Ability to give informed consent
Who cannot join
- Not sufficiently stable to take part in an interview
- Not sufficiently fluent in English to take part in an interview
- STAFF PARTICIPANTS
- Not sufficiently fluent in English to take part in an interview
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
University of Sussex
Brighton
Cardiff University
Cardiff
University of Edinburgh
Edinburgh
University of Glasgow
Glasgow
King's College London
London
University of Manchester
Manchester, Greater Manchester, M13 9PL
About this study
Official title: 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.
- Conditions
- Psychosis, Schizophrenia, Schizoaffective Disorder
- Being tested
- No intervention. Participants will take part in a qualitative interview
- Keywords
- smartphone app, wearable, digital health tool, symptom monitoring, passive sensing, mental health, SMI, severe mental health problems
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Participants will take part in a qualitative interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Service users | Service users with experience of schizophrenia spectrum psychosis Receives: 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 Receives: Other: No intervention. Participants will take part in a qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour
Secondary outcomes (1)
Demographics
Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Academic Health Science Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, University of Edinburgh, King's College London, Cardiff University, University of Sussex
- Responsible party
- Principal investigator, Sandra Bucci, Manchester Academic Health Science Centre
- Investigators
- Sandra Bucci, ClinPsyD, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670197
- Sponsor's protocol ID
- NHS001961
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Service User and Staff Views on Digital Remote Monitoring for Unusual Distressing Experiences (psychosis)
- ClinicalTrials.gov ID
- NCT05670197
- Acronym / sponsor ID
- NHS001961
- Conditions
- Psychosis, Schizophrenia, Schizoaffective Disorder
- Keywords
- smartphone app, wearable, digital health tool, symptom monitoring, passive sensing, mental health, SMI, severe mental health problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Manchester Academic Health Science CentreUniversity, hospital or other
- Collaborators
- University of Glasgow, University of Edinburgh, King's College London, Cardiff University, University of Sussex
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Service users | – | Other: No intervention. Participants will take part in a qualitative interviewService users with experience of schizophrenia spectrum psychosis |
| Mental health staff | – | Other: No intervention. Participants will take part in a qualitative interviewMental health staff who work within an adult NHS service providing mental health support to people who experience schizophrenia spectrum psychosis / severe mental health problems |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
- Work within an adult NHS service providing mental health support to people who experience psychosis / severe mental health problems
Key exclusion criteria (4 listed)
- Not sufficiently stable to take part in an interview
- Not sufficiently fluent in English to take part in an interview
- STAFF PARTICIPANTS
- Not sufficiently fluent in English to take part in an interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Participants will take part in a qualitative interviewNo 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. | Other | Mental health staff, Service users |
Primary outcome
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.
1 secondary outcome
Demographics
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Bucci, ClinPsyD study chair
University of Manchester
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia, run by Manchester Academic Health Science Centre at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service user and staff views on complex digital remote monitoring (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.