title: Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Cognitive 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
  We 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.
  
  
  CONCLUSIONS
  To 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.
  
  
  BACKGROUND
  ISRCTN34966555. Date of first registration: 12 June 2014.
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. sandra.bucci@manchester.ac.uk.
authors.forename: Sandra
authors.initials: S
authors.lastname: Bucci
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. christine.barrowclough@manchester.ac.uk.
authors.forename: Christine
authors.initials: C
authors.lastname: Barrowclough
authors.affiliation: Centre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. john.ainsworth@manchester.ac.uk.|Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, M13 9PL, Manchester, UK. john.ainsworth@manchester.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Ainsworth
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. rohan.morris@manchester.ac.uk.
authors.forename: Rohan
authors.initials: R
authors.lastname: Morris
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. katherine.berry@manchester.ac.uk.
authors.forename: Katherine
authors.initials: K
authors.lastname: Berry
authors.affiliation: Centre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. matthew.machin@manchester.ac.uk.|Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, M13 9PL, Manchester, UK. matthew.machin@manchester.ac.uk.
authors.forename: Matthew
authors.initials: M
authors.lastname: Machin
authors.affiliation: Centre for Biostatistics, Institute of Population Health, The University of Manchester & Manchester Academic Health Science Centre, Jean McFarlane Building, Oxford Road, M13 9PL, Manchester, UK. richard.emsley@manchester.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Emsley
authors.affiliation: Institute of Brain, Behaviour and Mental Health, Manchester Academic Health Sciences Centre and Manchester Mental Health and Social Care Trust, Manchester, M13 9PL, UK. shon.lewis@manchester.ac.uk.
authors.forename: Shon
authors.initials: S
authors.lastname: Lewis
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. dawn.edge@manchester.ac.uk.
authors.forename: Dawn
authors.initials: D
authors.lastname: Edge
authors.affiliation: Centre for Health Informatics, Institute of Population Health, University of Manchester, M13 9PL, Manchester, UK. buchan@manchester.ac.uk.|Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, M13 9PL, Manchester, UK. buchan@manchester.ac.uk.
authors.forename: Iain
authors.initials: I
authors.lastname: Buchan
authors.affiliation: School of Psychological Sciences, The University of Manchester, Zochonis Building, Brunswick Street, M13 9PL, Manchester, UK. gillian.haddock@manchester.ac.uk.
authors.forename: Gillian
authors.initials: G
authors.lastname: Haddock
mesh_terms: D000208:Acute Disease; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000295:instrumentation* / Q000379:methods; D004739:England; D005240:Feasibility Studies; D006801:Humans; D063731:Mobile Applications; D017060:Patient Satisfaction; D011209:Power, Psychological; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012008:Recurrence; D012107:Research Design; D016037:Single-Blind Method; D000068997:Smartphone; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome