Schizophrenia RelapseExPRESS:2NCT03558529
Feasibility and Acceptability of a Smartphone App to Assess Early Warning Signs of Psychosis Relapse
An observational study of Schizophrenia Relapse and Schizophrenia, run by Manchester Academic Health Science Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Relapse, Schizophrenia, Schizo Affective Disorder
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: ExPRESS:2 (Experiences of Psychosis Relapse: Early Subjective Signs) Longitudinal Feasibility Study
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.
Read more
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.
Read the 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).
- Conditions
- Schizophrenia Relapse, Schizophrenia, Schizo Affective Disorder, Psychotic Disorders, Psychosis
- Keywords
- relapse, early signs, basic symptoms, smartphone app, mhealth
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weekly app assessments completed per person during 6 month followup period
This is used as an indicator of the feasibility of using an app for 6 months
Measured: 6 months
Secondary outcomes (6)
Percentage of participants completing at least 33% of weekly app assessments during the 6 month followup period (retention)
This is used as an indicator of the feasibility of using an app for 6 months
Measured: 6 months
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
Symptom increase criteria were: for remitted individuals, an increase to four or above or an increase of at least two points (whichever was higher) on any item; for non-remitted individuals with all baseline PANSS positive items <5, at least one item ≥5; for non-remitted individuals with at least one baseline PANSS positive item ≥5, an increase of at least one point on any item. Individuals' initial remission status was determined from baseline PANSS interview using standard criteria. Remission status was updated during follow-up, based on app-assessed symptoms, using a parallel of the standard remission criteria (decrease to 3 or below on all app-assessed psychotic symptoms, for two consecutive weeks).
Measured: 6 months
Selected items from the Basic Symptoms Checklist
Weekly basic symptoms, assessed using items from the Basic Symptoms Checklist within the ExPRESS app
Measured: Weekly for 6 months
Selected items from the Early Signs Scale
Weekly conventional early signs of relapse, assessed using items from the Early Signs Scale within the ExPRESS app
Measured: Weekly for 6 months
Selected items derived from the Positive and Negative Syndrome Scale (PANSS)
Weekly psychotic symptoms, assessed using items derived from the Positive and Negative Syndrome Scale, within the ExPRESS app
Measured: Weekly for 6 months
Qualitative data from participant interviews regarding their experiences of using the ExPRESS app for 6 months
This is an indicator of acceptability of using an app for 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 May 2015
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia RelapseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Academic Health Science Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Eisner, Manchester Academic Health Science Centre
- Investigators
- Emily Eisner, BA, MRes, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558529
- Sponsor's protocol ID
- 157360
- Other IDs
- MR/J500410/1, MR/K500823/1, MR/K501311/1
- Acronym
- ExPRESS:2
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eisner E, Drake R, Lobban F, Bucci S, Emsley R, Barrowclough C. Comparing early signs and basic symptoms as methods for predicting psychotic relapse in clinical practice. Schizophr Res. 2018 Feb;192:124-130. doi: 10.1016/j.schres.2017.04.050. Epub 2017 May 9.
PubMed 28499766Eisner E, Drake R, Barrowclough C. Assessing early signs of relapse in psychosis: review and future directions. Clin Psychol Rev. 2013 Jul;33(5):637-53. doi: 10.1016/j.cpr.2013.04.001. Epub 2013 Apr 11.
PubMed 23628908Eisner E, Barrowclough C, Lobban F, Drake R. Qualitative investigation of targets for and barriers to interventions to prevent psychosis relapse. BMC Psychiatry. 2014 Jul 16;14:201. doi: 10.1186/1471-244X-14-201.
PubMed 25030092Robinson D, Woerner MG, Alvir JM, Bilder R, Goldman R, Geisler S, Koreen A, Sheitman B, Chakos M, Mayerhoff D, Lieberman JA. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999 Mar;56(3):241-7. doi: 10.1001/archpsyc.56.3.241.
PubMed 10078501Appleby L. Suicide in psychiatric patients: risk and prevention. Br J Psychiatry. 1992 Dec;161:749-58. doi: 10.1192/bjp.161.6.749.
PubMed 1483160Wiersma D, Nienhuis FJ, Slooff CJ, Giel R. Natural course of schizophrenic disorders: a 15-year followup of a Dutch incidence cohort. Schizophr Bull. 1998;24(1):75-85. doi: 10.1093/oxfordjournals.schbul.a033315.
PubMed 9502547Mangalore R, Knapp M. Cost of schizophrenia in England. J Ment Health Policy Econ. 2007 Mar;10(1):23-41.
PubMed 17417045Almond S, Knapp M, Francois C, Toumi M, Brugha T. Relapse in schizophrenia: costs, clinical outcomes and quality of life. Br J Psychiatry. 2004 Apr;184:346-51. doi: 10.1192/bjp.184.4.346.
PubMed 15056580Herz MI, Lamberti JS, Mintz J, Scott R, O'Dell SP, McCartan L, Nix G. A program for relapse prevention in schizophrenia: a controlled study. Arch Gen Psychiatry. 2000 Mar;57(3):277-83. doi: 10.1001/archpsyc.57.3.277.
PubMed 10711914Lee SH, Choi TK, Suh S, Kim YW, Kim B, Lee E, Yook KH. Effectiveness of a psychosocial intervention for relapse prevention in patients with schizophrenia receiving risperidone via long-acting injection. Psychiatry Res. 2010 Feb 28;175(3):195-9. doi: 10.1016/j.psychres.2008.06.043.
PubMed 20022120Gumley A, O'Grady M, McNay L, Reilly J, Power K, Norrie J. Early intervention for relapse in schizophrenia: results of a 12-month randomized controlled trial of cognitive behavioural therapy. Psychol Med. 2003 Apr;33(3):419-31. doi: 10.1017/s0033291703007323.
PubMed 12701663Birchwood M, Smith J, Macmillan F, Hogg B, Prasad R, Harvey C, Bering S. Predicting relapse in schizophrenia: the development and implementation of an early signs monitoring system using patients and families as observers, a preliminary investigation. Psychol Med. 1989 Aug;19(3):649-56. doi: 10.1017/s0033291700024247.
PubMed 2798634Gumley AI, MacBeth A, Reilly JD, O'Grady M, White RG, McLeod H, Schwannauer M, Power KG. Fear of recurrence: results of a randomized trial of relapse detection in schizophrenia. Br J Clin Psychol. 2015 Mar;54(1):49-62. doi: 10.1111/bjc.12060. Epub 2014 Jul 8.
PubMed 25040487Norman RM, Malla AK. Prodromal symptoms of relapse in schizophrenia: a review. Schizophr Bull. 1995;21(4):527-39. doi: 10.1093/schbul/21.4.527.
PubMed 8749881Fusar-Poli P, Bonoldi I, Yung AR, Borgwardt S, Kempton MJ, Valmaggia L, Barale F, Caverzasi E, McGuire P. Predicting psychosis: meta-analysis of transition outcomes in individuals at high clinical risk. Arch Gen Psychiatry. 2012 Mar;69(3):220-9. doi: 10.1001/archgenpsychiatry.2011.1472.
PubMed 22393215
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExPRESS:2 (Experiences of Psychosis Relapse: Early Subjective Signs) Longitudinal Feasibility Study
- ClinicalTrials.gov ID
- NCT03558529
- Acronym / sponsor ID
- ExPRESS:2 / 157360
- Conditions
- Schizophrenia Relapse, Schizophrenia, Schizo Affective Disorder, Psychotic Disorders, Psychosis
- Keywords
- relapse, early signs, basic symptoms, smartphone app, mhealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Manchester Academic Health Science CentreUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 15 Jun 2018 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of weekly app assessments completed per person during 6 month followup period
Time frame: 6 months
This is used as an indicator of the feasibility of using an app for 6 months
6 secondary outcomes
Percentage of participants completing at least 33% of weekly app assessments during the 6 month followup period (retention)
Time frame: 6 months
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
Time frame: 6 months
Selected items from the Basic Symptoms Checklist
Time frame: Weekly for 6 months
Selected items from the Early Signs Scale
Time frame: Weekly for 6 months
Selected items derived from the Positive and Negative Syndrome Scale (PANSS)
Time frame: Weekly for 6 months
Qualitative data from participant interviews regarding their experiences of using the ExPRESS app for 6 months
Time frame: 6 months
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 15 Jun 2018.
- Background: PubMed 28499766Eisner E, Drake R, Lobban F, Bucci S, Emsley R, Barrowclough C. Comparing early signs and basic symptoms as methods for predicting psychotic relapse in clinical practice. Schizophr Res. 2018 Feb;192:124-130. doi: 10.1016/j.schres.2017.04.050. Epub 2017 May 9.
- Background: PubMed 23628908Eisner E, Drake R, Barrowclough C. Assessing early signs of relapse in psychosis: review and future directions. Clin Psychol Rev. 2013 Jul;33(5):637-53. doi: 10.1016/j.cpr.2013.04.001. Epub 2013 Apr 11.
- Background: PubMed 25030092Eisner E, Barrowclough C, Lobban F, Drake R. Qualitative investigation of targets for and barriers to interventions to prevent psychosis relapse. BMC Psychiatry. 2014 Jul 16;14:201. doi: 10.1186/1471-244X-14-201.
- Background: PubMed 10078501Robinson D, Woerner MG, Alvir JM, Bilder R, Goldman R, Geisler S, Koreen A, Sheitman B, Chakos M, Mayerhoff D, Lieberman JA. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 1999 Mar;56(3):241-7. doi: 10.1001/archpsyc.56.3.241.
- Background: PubMed 1483160Appleby L. Suicide in psychiatric patients: risk and prevention. Br J Psychiatry. 1992 Dec;161:749-58. doi: 10.1192/bjp.161.6.749.
- Background: PubMed 9502547Wiersma D, Nienhuis FJ, Slooff CJ, Giel R. Natural course of schizophrenic disorders: a 15-year followup of a Dutch incidence cohort. Schizophr Bull. 1998;24(1):75-85. doi: 10.1093/oxfordjournals.schbul.a033315.
- Background: PubMed 17417045Mangalore R, Knapp M. Cost of schizophrenia in England. J Ment Health Policy Econ. 2007 Mar;10(1):23-41.
- Background: PubMed 15056580Almond S, Knapp M, Francois C, Toumi M, Brugha T. Relapse in schizophrenia: costs, clinical outcomes and quality of life. Br J Psychiatry. 2004 Apr;184:346-51. doi: 10.1192/bjp.184.4.346.
- Background: PubMed 10711914Herz MI, Lamberti JS, Mintz J, Scott R, O'Dell SP, McCartan L, Nix G. A program for relapse prevention in schizophrenia: a controlled study. Arch Gen Psychiatry. 2000 Mar;57(3):277-83. doi: 10.1001/archpsyc.57.3.277.
- Background: PubMed 20022120Lee SH, Choi TK, Suh S, Kim YW, Kim B, Lee E, Yook KH. Effectiveness of a psychosocial intervention for relapse prevention in patients with schizophrenia receiving risperidone via long-acting injection. Psychiatry Res. 2010 Feb 28;175(3):195-9. doi: 10.1016/j.psychres.2008.06.043.
- Background: PubMed 12701663Gumley A, O'Grady M, McNay L, Reilly J, Power K, Norrie J. Early intervention for relapse in schizophrenia: results of a 12-month randomized controlled trial of cognitive behavioural therapy. Psychol Med. 2003 Apr;33(3):419-31. doi: 10.1017/s0033291703007323.
- Background: PubMed 2798634Birchwood M, Smith J, Macmillan F, Hogg B, Prasad R, Harvey C, Bering S. Predicting relapse in schizophrenia: the development and implementation of an early signs monitoring system using patients and families as observers, a preliminary investigation. Psychol Med. 1989 Aug;19(3):649-56. doi: 10.1017/s0033291700024247.
- Individual participant dataSharing planned: Undecided
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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.
Emily Eisner, BA, MRes principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia Relapse and Schizophrenia, run by Manchester Academic Health Science Centre.
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 8 inclusion and 3 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of weekly app assessments completed per person during 6 month followup period (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558529, which also lists 17 linked publications.
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 15 Jun 2018.