Implementation of a Digital Cognitive Behavioural Therapy Intervention for Insomnia in First Episode Psychosis in the Context of Covid19: A Mixed Methods Study

First episode psychosis (FEP) services present a unique opportunity to effect change in outcomes in those affected by experiences of psychosis. Sleep disorder, particularly insomnia, is common in those affected by psychosis, including those experiencing a first episode and are associated with increased symptomatology. Mood and worry mediate the relationship between sleep and psychosis symptomatology and research suggests that improving sleep in this population can improve mental health symptomatology and longer term outcomes. Cognitive Behavioural Therapy is effective in treating insomnia (CBT-I). Pilot research suggests that insomnia is a tractable clinical target in psychosis. Furthermore, there is an appetite for therapeutic interventions for sleep in this population.

"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. Sleepio's components are those common to CBT-I interventions: i) Psychoeducation on sleep hygiene and processes; ii) cognitive components including restructuring, mindfulness, positive imagery, paradoxical intention training (trying to stay awake), and resolving thoughts about one's day; and iii) behavioural components including sleep restriction, stimulus control, and relaxation techniques. Sleepio is composed of six 20-minute sessions presented by an animated therapist ("the Professor"), which are unlocked weekly. Participants complete an initial assessment (please see 'Sleepio Onboarding Questions') and chose a treatment goal, which drives initial personalisation of the application. Participants book digital 'appointments' with the Professor and receive prompts to complete these 6 sessions, to enter sleep data and to complete the Sleep Condition Indicator. The Sleepio algorithm tailors ongoing intervention based on this sleep data and other data about participants' physical and mental health. Sleepio also provides access to online psychoeducation and a clinician-moderated user forum. This intervention has been shown to be as effective as 1-1 CBT-I in the general population. Sleepio has been used in mental health populations but has not yet been tested in people experiencing a first episode of psychosis.

The study aims to use mixed methods to determine how digital CBT-I can be implemented in first episode psychosis services. These data will be integrated to build a logic model, based on the Medical Research Council (MRC) complex interventions framework.

Keyworkers in Esteem FEP services will be approached to identify service users affected by sleep difficulties that may benefit from Sleepio. Service user participants will be recruited through their treatment as usual (TAU) with their Esteem keyworker (sleep monitoring is part of this). Where service users report sleep difficulties, keyworkers will offer an information leaflet about the study and referral into the research study or contact details for researchers (study email address). Keyworkers will record that service users have agreed to keyworkers providing their details to researchers and to being contacted by the researchers in their casefile.

Those service users who wish to find out more about the study and meet eligibility criteria will be sent an easy-read Participant Information Sheet and Consent Form. They will be given the opportunity to ask questions and will be encouraged to speak to others about their potential participation (such as their keyworker). It will be made clear that in consenting to participate they are consenting to participate in sleep assessment, complete symptomatology measures pre- and post-intervention and use the Sleepio intervention. It will be made clear that participation does not affect their TAU. They will provide written consent if they wish to participate. Consenting service user study participants will receive access to Sleepio. They will register for the intervention with a researcher during the baseline symptomology measures assessment session.