Clinical trial NCT03558529: Feasibility and Acceptability of a Smartphone App to Assess Early Warning Signs of Psychosis Relapse
Official title: ExPRESS:2 (Experiences of Psychosis Relapse: Early Subjective Signs) Longitudinal Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia Relapse
Schizophrenia
Schizo Affective Disorder
Psychotic Disorders
Psychosis
Keywords: relapse
early signs
basic symptoms
smartphone app
mhealth
Lead sponsor: Manchester Academic Health Science Centre
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a schizophrenia spectrum diagnosis who have experienced at least one episode within the past year (or at least two within the past year) were recruited from three NHS mental health trusts in the North West of England.

Brief summary: About 1 in 100 people will experience an episode of psychosis. Some people will only experience one 'psychotic episode' and about a quarter of people make a full recovery. Others will have recurring periods of problems ('relapses'), perhaps at times of particular stress. As people often find psychosis distressing, this study looks at ways to help them stay well in the future.

There is growing evidence that 'early signs' interventions can prevent relapses of psychosis. Early signs are things that might happen when people start to become unwell. For example some people start to sleep badly when they are becoming unwell. Most people with psychosis can identify early signs emerging in the weeks before relapse. In early signs interventions, service users are taught to recognise early signs that their mental health may be deteriorating so that they can take action to avoid becoming unwell.

Although early signs interventions show promise, the investigators suggest that they can be improved by more accurate assessment of relapse risk. This might be achieved by monitoring 'basic symptoms' in addition to conventional early signs of relapse. Basic symptoms are subtle, subclinical disturbances in one's experience of oneself and the world. Typical basic symptoms include: changes in perceptions, such as increased vividness of colour vision; impaired tolerance to certain stressors; difficulty finding or understanding common words.

In this study the investigators want to design and test a mobile phone app to help monitor basic symptoms. They hope that the app might help service users to stay well in the future. During the study the investigators will ask participants to use the app once a week for 6 months. At the end of the study they will interview them about their experiences of using the phone app and participating in the study.

Detailed description: BACKGROUND

Around 80% of those treated for a first episode of psychosis relapse within five years, with cumulative relapse rates of 78% and 86% for second and third relapses during this period. Relapses can be devastating for the individual and their family, may lead to a deteriorating course of illness and frequently require hospital admission, the principal source of schizophrenia's annual direct cost to the NHS of over £3.9 billion. Given the prevalence and considerable negative consequences of relapse, it is clear that relapse prevention strategies for those with psychosis are a priority.

There is growing evidence that interventions monitoring 'early signs' can be effective in preventing relapses of psychosis. Such interventions work on the premise that timely prediction of relapses will allow preventative action to be taken, minimizing the chance of full relapse occurring. The patient is assisted in identifying and monitoring early signs of relapse, and in developing concrete action plans for dealing with them (e.g. short term medication increases, stress reduction techniques, intensive psychological support). Early signs reported to emerge in the weeks before a relapse include: anxiety, dysphoria, insomnia, poor concentration, attenuated psychotic symptoms (Early Signs Scale, ESS) and fear of relapse (Fear of Recurrence Scale, FoRSe). However, such checklists are only modestly predictive of relapse so they could be improved by including more specific psychopathology.

Evidence suggests that 'basic symptoms' may be useful relapse indicators that could be added to checklists of conventional early warning signs to improve predictive power. Studies in individuals at high risk of psychosis have characterised basic symptoms as subtle, sub-clinical, qualitative disturbances in one's experience of oneself and the world which are predictive of transition to first episode psychosis. Typical basic symptoms include: changes in perceptions, such as increased vividness of colour vision; mild subjective cognitive problems; impaired tolerance to certain stressors; subjective difficulty finding or understanding common words. Two retrospective studies examining service users' experiences in the run up to a recent relapse of psychosis provide preliminary evidence that basic symptoms occur prior to relapse.

AIMS

The long term aim is to conduct a definitive study to prospectively investigate the predictive value of basic symptoms as early signs of psychosis relapse using a mobile phone application to monitor these within individuals' everyday lives. In line with the Medical Research Council guide for developing complex interventions a feasibility study will be conducted first. This study has four phases. In Phase 1 the investigators will design a measure of basic symptoms, assessed via smart-phone, and adapt it as applicable following feedback from participants. Phase 2 begins with a screening interview to identify participants with at least one basic symptom; these individuals will be eligible for Phase 3 (since past basic symptoms are likely to predict future basic symptoms). Cross-sectional assessments will also be conducted in Phase 2; by comparing those with and without basic symptoms the investigators will begin to characterise the sub-group of individuals with whom the basic symptom assessment can be used. In Phase 3 a prospective, longitudinal design will be used to investigate the feasibility of using a mobile phone application to regularly measure basic symptoms, conventional early signs and relapse over an extended period. Finally, in Phase 4, participants' experiences of using the phone application will be explored using qualitative interviews (acceptability).

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* current contact with mental health services
* a current, primary clinical diagnosis of non-affective psychotic disorder (DSM-IV)
* at least one episode of acute psychosis in the past year (admission to crisis team or hospital; or exacerbation of psychotic symptoms lasting at least 2 weeks and leading to a change in management), or at least two episodes of psychosis in the past 2 years, including index episode
* currently prescribed antipsychotic medication
* fluency in English
* fixed abode
* informed consent.

Exclusion Criteria:

* not sufficiently stable to take part (unable to complete screening assessment)
* significant history of organic factors implicated in the aetiology of psychotic symptoms
* current alcohol or drug dependence

Primary outcomes:
measure: Percentage of weekly app assessments completed per person during 6 month followup period
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of participants completing at least 33% of weekly app assessments during the 6 month followup period (retention)
timeFrame: 6 months
measure: Relapse rate: a symptom increase (measured using five PANSS items: delusions, hallucinations, grandiosity, suspiciousness, thought disorder) for at least one week that resulted in a management change as reported in casenotes
timeFrame: 6 months
measure: Selected items from the Basic Symptoms Checklist
timeFrame: Weekly for 6 months
measure: Selected items from the Early Signs Scale
timeFrame: Weekly for 6 months
measure: Selected items derived from the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Weekly for 6 months
measure: Qualitative data from participant interviews regarding their experiences of using the ExPRESS app for 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Manchester
name: Emily Eisner, BA, MRes
role: PRINCIPAL_INVESTIGATOR
References:
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