Abstract
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.
Highlights
Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; only a small proportion of service users have access to this intervention
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
We will estimate parameters for the design of a future randomised controlled trial (RCT), such as testing recruitment strategies, identifying a suitable primary outcome measure for use in future research, drop-out rates, proportion of eligible participants consenting, proportion continuing for 12 weeks, proportion of data-points completed across all participants, examining the characteristics of outcome measures and estimating the standard deviation and intra-cluster correlation to aid in future sample size calculation, and collecting information on follow-up response rates
Summary
Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; only a small proportion of service users have access to this intervention. The early course of psychosis is characterised by repeated relapse; up to 80 % of service users will relapse within five years of the initial episode. This is significant because each relapse increases the risk of developing persistentpsychotic symptoms and further disconnection from school, work, friends and the community, adversely effecting long-term psychosocial development [2]. As the early course of psychosis is sharply predictive of the longer-term course of problems, timely, effective and accessible interventions have the potential to prevent the development of sustained and ongoing problems associated with more serious forms of psychosis
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