CONNECT: using electronic devices (e.g. smartphones, smartwatches) to predict relapse of psychosis

Plain English Summary

Background and study aims
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. Digital technologies offer 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. Healthcare apps can alert health professionals when someone needs extra support but can be burdensome to use long-term. We want to make a system that collects data in a timely manner, reduces the burden for both patients (by reducing the need to recall feelings) and staff and is more personalised. Recent research shows that information gathered routinely by individuals’ smartphones (e.g. activity levels) might help predict relapse in long-term conditions. We want to extend our work to develop an accurate and dynamic digital remote data collection system that predicts psychosis relapse.

Who can participate?
- Adults of working age (16 years and older);
- Within the past two years have had at least one acute episode of psychosis (including relapse and first episode) leading to an unscheduled episode of acute care, including inpatient admission or acute home treatment / crisis intervention;
- Received a clinical diagnosis of schizophrenia spectrum disorder (ICD10 F20 - 29);

What does the study involve?
Participants will be asked to wear a wrist-worn device (either a Fitbit or smartwatch) and carry a smartphone for 12 months. Collection of passively collected data will provide data on potential predictors of our outcome (relapse). We will not collect information that can directly identify the participant. Participants will also be prompted via the CONNECT app throughout the week to provide subjective information about symptoms, mood and other contextual items. The subjective report provides reliable insight into the variability of participants experiences over time. Every three months, we will ask participants to complete some questionnaires about, for example, their symptoms, mood, technology use and quality of life. At the end of the study period, participants will be given the opportunity to see and discuss the information collected about them with the research team and debrief about the study. A small number (n=60) will be asked to participate in an additional interview to find out more about their experiences of participating in the study.

What are the possible benefits and risks of participating?
Benefits:
- We hope our meetings and interviews will provide an open and comfortable space in which participants can feel free to share their thoughts, feelings, and opinions. Participants in previous studies have commented that they enjoyed the opportunity to discuss their experiences with a researcher.
- Participants may also find that being involved in research which aims to inform mental health care will empower them. The researcher will ensure that the participants are aware of how important and valued their contribution is to the study and potentially the treatment of psychosis in the future.
- The Lived Experience Advisory Panel has reported that contributing to new knowledge has the potential to transform the way in which people with lived experience of psychosis interact with services, the way in which services deliver care, and the ability to stay well in the future.
- At the end of the study, we will provide each participant with a summary of their information and provide an opportunity to talk about it with the research team. Learning more about how their sleep, thoughts and feelings, behaviours and phone usage relates to their mood and symptoms will allow opportunity for improved self-management and insight, and communication with their healthcare provider.
Risks:
- Sensitive / potentially distressing topics.
The questions the researchers will be asking in the research assessments can include sensitive and emotive distressing topics, and this may have an impact on members of our research team involved in the planned data collection activities. Research workers will have weekly supervision with a qualified member of the team, and monthly joint supervision with the project clinical team member. They can also request additional supervision with the site leads should they need support more urgently. These systems will ensure appropriate opportunities for raising, discussing and resolving any emotive or challenging issues arising from the assessments conducted as part of this study, and the implementation of steps for ensuring that all research workers will be optimally supported. The research workers will also receive appropriate training in distress management from their local Trusts and from an experienced clinician.
- Participants may find using the wearable device, or answering questions on the CONNECT app, difficult or unsettling. If they do, they will be able to discuss this with a member of our team or with an NHS professional they already know. The research team will try to help them feel at ease and remind them that they do not have to answer any questions they do not want to. They can ask the researcher to move on or stop the assessment altogether if they find any of the questions upsetting. We hope this study will help us learn how to make the app and wearable easier to use, and will ask participants about any difficulties at the end of the study.
- Some people may feel uncomfortable having some information about their sleep or location collected. We will make sure to explain exactly what data is being collected, and how we will protect the participant’s confidentiality. Participants can also contact the research team at any time if they feel unhappy about any part of the study.
- The wearables used in this research are very safe; they are commercially available devices and have undergone extensive safety testing. There is a very small chance a participant may develop a skin rash on the part of the wrist where the wearable device is worn, in which case they can remove it. We also ask that participants do not complete the questions on the smartphone apps when in a situation where they need to pay attention, such as driving or crossing the road.
- There is a small risk that the technologies used in this study could be hacked. If this occurrs, we will immediately follow relevant procedures to fix this. However, this risk is the same as with any smartphone or commercial fitness tracker use. The encryption and data de-identification processes have been put in place to minimise any risk to the participant in the unlikely event of hacking.

Where is the study run from?
The University of Manchester (UK)

When is the study starting and how long is it expected to run for?
October 2020 to December 2026

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Dr Jane Lees, Project Manager
Jane.Lees@manchester.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone	+44 1612755436
Email	fbmhethics@manchester.ac.uk
Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Research organisation

Results and Publications

Editorial Notes

09/04/2024: The following changes have been made:
1. The recruitment start date has been changed from 15/01/2024 to 01/03/2024.
2. Study contact was updated.
02/01/2024: The recruitment start date has been changed from 02/01/2024 to 15/01/2024.
13/12/2023: The recruitment start date was changed from 01/12/2023 to 02/01/2024.
20/02/2023: Trial's existence confirmed by the NIHR.