Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial

BackgroundCognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT.Methods/DesignWe present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app.DiscussionTo our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care.Trial registrationISRCTN34966555. Date of first registration: 12 June 2014.

[1]  William Gibson,et al.  Working with Qualitative Data , 2009, QMiP Bulletin.

[2]  A. Morrison.  THE INTERPRETATION OF INTRUSIONS IN PSYCHOSIS: AN INTEGRATIVE COGNITIVE APPROACH TO HALLUCINATIONS AND DELUSIONS , 2001, Behavioural and Cognitive Psychotherapy.

[3]  E. Eisner,et al.  An investigation of the implementation of NICE-recommended CBT interventions for people with schizophrenia , 2014, Journal of mental health.

[4]  E. Granholm,et al.  Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. , 2012, Schizophrenia bulletin.

[5]  Julius Sim,et al.  The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. , 2012, Journal of clinical epidemiology.

[6]  Steven A. Julious,et al.  Sample size of 12 per group rule of thumb for a pilot study , 2005 .

[7]  M. Cowie.  National Institute for Health and Care Excellence. , 2015, European heart journal.

[8]  E S Rogers,et al.  A consumer-constructed scale to measure empowerment among users of mental health services. , 1997, Psychiatric services.

[9]  S. Bucci,et al.  Cognitive Therapy for Command Hallucinations: An advanced practical companion , 2013 .

[10]  J. Garske,et al.  Relation of the therapeutic alliance with outcome and other variables: a meta-analytic review. , 2000, Journal of consulting and clinical psychology.

[11]  I. Needleman,et al.  CONSORT. Consolidated Standards of Reporting Trials. , 1999, British dental journal.

[12]  J. Teasdale,et al.  Predictors of relapse in unipolar depressives: expressed emotion, marital distress, and perceived criticism. , 1989, Journal of abnormal psychology.

[13]  D. Chambless,et al.  Expressed emotion and behavior therapy outcome: a prospective study with obsessive-compulsive and agoraphobic outpatients. , 1999, Journal of consulting and clinical psychology.

[14]  N. Tarrier,et al.  The Psychotic Symptom Rating Scales (PSYRATS): Their usefulness and properties in first episode psychosis , 2007, Schizophrenia Research.

[15]  S. Kay,et al.  The positive and negative syndrome scale (PANSS) for schizophrenia. , 1987, Schizophrenia bulletin.

[16]  P. Williamson,et al.  Design and analysis of pilot studies: recommendations for good practice. , 2004, Journal of evaluation in clinical practice.

[17]  Linda C. Sobell,et al.  Timeline Follow-Back A Technique for Assessing Self-Reported Alcohol Consumption , 1992 .

[18]  Christine Barrowclough,et al.  A Comparison of Two Delivery Modalities of a Mobile Phone-Based Assessment for Serious Mental Illness: Native Smartphone Application vs Text-Messaging Only Implementations , 2013, Journal of medical Internet research.

[19]  D. Ben-Zeev,et al.  Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. , 2014, Schizophrenia bulletin.

[20]  F. Kay-Lambkin,et al.  Cognitive-behavioural therapy for substance use disorders in people with psychotic disorders , 2006, British Journal of Psychiatry.

[21]  E. Peters.  An oversimplification of psychosis, its treatment, and its outcomes? , 2014, British Journal of Psychiatry.

[22]  Kate Cavanagh,et al.  (Inter)personal Computing: The Role of the Therapeutic Relationship in E-mental Health , 2013, Journal of Contemporary Psychotherapy.

[23]  J. Ritchie,et al.  Qualitative Research Practice: A Guide for Social Science Students and Researchers , 2013 .

[24]  M. Birchwood,et al.  Cognitive therapy for command hallucinations: randomised controlled trial , 2004, British Journal of Psychiatry.

[25]  E. Kuipers,et al.  A cognitive model of the positive symptoms of psychosis , 2001, Psychological Medicine.

[26]  G. Gmel,et al.  Measuring Alcohol Consumption , 2004 .

[27]  P. Morosini,et al.  Development, reliability and acceptability of a new version of the DSM‐IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social funtioning , 2000, Acta psychiatrica Scandinavica.

[28]  A. Sergejew,et al.  Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses , 2000, Schizophrenia Research.

[29]  K. Berry,et al.  The role of expressed emotion in relationships between psychiatric staff and people with a diagnosis of psychosis: a review of the literature. , 2011, Schizophrenia bulletin.

[30]  D. Moher,et al.  CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials , 2010, Journal of pharmacology & pharmacotherapeutics.

[31]  Peter B. Jones,et al.  A population-level prediction tool for the incidence of first-episode psychosis: translational epidemiology based on cross-sectional data , 2013, BMJ Open.

[32]  Tomáš Novák,et al.  ITAREPS: Information Technology Aided Relapse Prevention Programme in Schizophrenia , 2008, Schizophrenia Research.

[33]  S. Lewis,et al.  Psychological interventions in early psychosis. , 2005, Schizophrenia bulletin.

[34]  P. McGorry,et al.  Risk factors for relapse following treatment for first episode psychosis: A systematic review and meta-analysis of longitudinal studies , 2012, Schizophrenia Research.

[35]  D. Klein,et al.  Covergent and Discriminant Validity of Perceived Criticism From Spouses and Family Members , 1996 .

[36]  A. Kasuya.  EuroQol--a new facility for the measurement of health-related quality of life. , 1990, Health policy.

[37]  A. Wells,et al.  Cognitive Therapy of Anxiety Disorders: A Practice Manual and Conceptual Guide , 1997, Journal of Cognitive Psychotherapy.

[38]  N. Tarrier,et al.  Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS) , 1999, Psychological Medicine.

[39]  N. Tarrier,et al.  Coping Strategy Enhancement (CSE): A Method of Treating Residual Schizophrenic Symptoms , 1990, Behavioural and Cognitive Psychotherapy.

[40]  P. Harris,et al.  Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support , 2009, J. Biomed. Informatics.

[41]  R. Salvador,et al.  Cognitive-behavioural therapy for the symptoms of schizophrenia: systematic review and meta-analysis with examination of potential bias. , 2014, The British journal of psychiatry : the journal of mental science.

[42]  Diagnostic and Statistical Manual , 2010 .

[43]  Anthony P Morrison,et al.  What are the components of CBT for psychosis? A Delphi study. , 2010, Schizophrenia bulletin.

[44]  J. Lieberman,et al.  Psychosocial treatment for first-episode psychosis: a research update. , 2005, The American journal of psychiatry.

[45]  J. Ainsworth,et al.  The feasibility and validity of ambulatory self-report of psychotic symptoms using a smartphone software application , 2012, BMC Psychiatry.

[46]  Jean Addington,et al.  A depression rating scale for schizophrenics , 1990, Schizophrenia Research.

[47]  N. Tarrier,et al.  Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and comorbid substance misuse: randomised controlled trial , 2010, BMJ : British Medical Journal.

[48]  A. Beck,et al.  Beck Depression Inventory–II , 2011 .

[49]  K. Carey,et al.  Temporal stability of the timeline followback interview for alcohol and drug use with psychiatric outpatients. , 2004, Journal of studies on alcohol.

[50]  A. Williams.  EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[51]  B. Everitt,et al.  Cognitive Behavior Therapy for Schizophrenia: Effect Sizes, Clinical Models, and Methodological Rigor , 2007, Schizophrenia bulletin.