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

CONNECT: Digital markers to predict psychosis relapse

Registry ID
ISRCTN24746936
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Manchester
Enrollment
1100
Start date
2024-03-01
Completion date
2028-07-31
Last update
2026-08-17

Conditions

Summary

Psychosis

Detailed description

Current interventions, as of 23/05/2025: We aim to recruit 1100 relapse-prone individuals with a schizophrenia spectrum diagnosis. To achieve our objectives, we will recruit one cohort (data will be split into two groups): - Group 1 (n = 800): in which we will collect data to derive and internally test a personalised relapse risk prediction algorithm using ASM items, passively collected behavioural, environmental and contextual data, integrated using machine learning (see statistical analysis section for details of the methods). We will also develop the adaptive sampling algorithm. - Group 2 (n = 300): in which we will apply and temporally test the risk prediction algorithm and the adaptive sampling algorithm from Group 1. Note the adaptive sampling algorithm will not change the data collection in any way, nor will it be used to monitor, prevent or treat psychosis; we will simply use the data collected to test the algorithm. This design of derivation/internal validation and subsequent temporal validation is appropriate to assess the algorithm’s validity. Group 2 acts as a temporal validation set to test the prediction model and the adaptive sampling model on previously unseen individuals (recruited latest in time). A future study will examine whether our predictive and adaptive sampling algorithms can improve clinical decision-making on early intervention for psychosis relapse (but this will not be tested in the proposed study). Nested pilot of the wearable device. To assess the feasibility and acceptability of different types of wearable devices, we conducted a smartwatch vs Fitbit comparison nested in the main cohort study for the first 100 participants consented into the study (minimum of n = 10 at each site to represent demographic/regional characteristics at each site). These participants were offered a choice of which wearable to use, and we monitored the acceptability and data quality of the wearable device selected. Specifically, we assessed which wearab

Interventions

Inclusion criteria

Current inclusion criteria as of 23/05/2025: Participants will be people with lived experience of psychosis on existing caseloads of secondary care mental health teams in NHS Trusts/Health Boards who are: 1. Adults of working age (16+ years) 2. Within the past 2 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 3. Received a clinical diagnosis of, or confirmed by the treating clinician to meet the criteria of, schizophrenia spectrum disorder (ICD10 F20 - 29) 4. Current presentation does not include severe acute symptoms 5. In accordance with the Mental Capacity Act, mental capacity will be assumed. If there is any doubt, then a capacity assessment will be carried out by a clinician from the study team or the responsible clinician _____ Previous inclusion criteria: Participants will be people with lived experience of psychosis on existing caseloads of secondary care mental health teams in NHS Trusts/Health Boards who are: 1. Adults of working age (16+ years) 2. Within the past 2 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 3. Received a clinical diagnosis of schizophrenia spectrum disorder (ICD10 F20 - 29) 4. Current presentation does not include severe acute symptoms 5. In accordance with the Mental Capacity Act, mental capacity will be assumed. If there is any doubt, then a capacity assessment will be carried out by a clinician from the study team or the responsible clinician

Exclusion criteria

Current exclusion criteria as of 23/05/2025: 1. Experienced a recent relapse within the previous 12 weeks as confirmed by the treating clinician 2. Non-English speaking _____ Previous exclusion criteria: 1. Experienced a recent relapse, operationally defined as having been discharged from the care of a crisis team/psychiatric inpatient service within the previous 12 weeks 2. Non-English speaking

Locations

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