Feasibility and Acceptability of a Smartphone App to Assess Early Warning Signs of Psychosis Relapse

NCT03558529 | Completed

• 4 other identifiers: 157360MR/J500410/1MR/K500823/1MR/K501311/1
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia Relapse; Schizophrenia; Schizo Affective Disorder; Psychotic Disorders; Psychosis

Keywords

relapse; early signs; basic symptoms; smartphone app; mhealth

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (6)

• Percentage of participants completing at least 33% of weekly app assessments during the 6 month followup period (retention)

  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

  6 months

• Selected items from the Basic Symptoms Checklist

  Weekly for 6 months

• Selected items from the Early Signs Scale

  Weekly for 6 months

• Selected items derived from the Positive and Negative Syndrome Scale (PANSS)

  Weekly for 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester Academic Health Science Centre: lead

Related Publications (17)

• 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.

  PMID: 28499766 BACKGROUND

• Eisner 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.

  PMID: 23628908 BACKGROUND

• Eisner 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.

  PMID: 25030092 BACKGROUND

• Robinson 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.

  PMID: 10078501 BACKGROUND

• Appleby L. Suicide in psychiatric patients: risk and prevention. Br J Psychiatry. 1992 Dec;161:749-58. doi: 10.1192/bjp.161.6.749.

  PMID: 1483160 BACKGROUND

• Wiersma 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.

  PMID: 9502547 BACKGROUND

• Mangalore R, Knapp M. Cost of schizophrenia in England. J Ment Health Policy Econ. 2007 Mar;10(1):23-41.

  PMID: 17417045 BACKGROUND

• Almond 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.

  PMID: 15056580 BACKGROUND

• Herz 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.

  PMID: 10711914 BACKGROUND

• Lee 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.

  PMID: 20022120 BACKGROUND

• Gumley 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.

  PMID: 12701663 BACKGROUND

• Birchwood 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.

  PMID: 2798634 BACKGROUND

• Gumley 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.

  PMID: 25040487 BACKGROUND

• Norman 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.

  PMID: 8749881 BACKGROUND

• Fusar-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.

  PMID: 22393215 BACKGROUND

• Bechdolf A, Schultze-Lutter F, Klosterkotter J. Self-experienced vulnerability, prodromal symptoms and coping strategies preceding schizophrenic and depressive relapses. Eur Psychiatry. 2002 Nov;17(7):384-93. doi: 10.1016/s0924-9338(02)00698-3.

  PMID: 12547304 BACKGROUND

• Eisner E, Drake RJ, Berry N, Barrowclough C, Emsley R, Machin M, Bucci S. Development and Long-Term Acceptability of ExPRESS, a Mobile Phone App to Monitor Basic Symptoms and Early Signs of Psychosis Relapse. JMIR Mhealth Uhealth. 2019 Mar 29;7(3):e11568. doi: 10.2196/11568.

  PMID: 30924789 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Recurrence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Eisner, BA, MRes

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06