This study uses mixed methods to investigate the implementation of digital cognitive
behavioural therapy for insomnia (Sleepio) in a first episode of psychosis service (FEP).
Interviews will be conducted with keyworker clinicians and service users to consider
their expectations for digital sleep intervention. The rates of recruitment into the
study, eligibility, completion of baseline measures, completion of the intervention
sessions, attrition from the intervention and completion of follow up measures will be
recorded. Interviews will be conducted with keyworker clinicians and service users to
consider their experiences of digital sleep intervention.

The primary outcome will be a logic model describing factors acting upon the
implementation of Sleepio in this population. The investigators will provide signal data
in relation to changes in insomnia severity, psychosis symptomatology, and general mental
health.

Implementation of Digital CBT for Insomnia in First Episode Psychosis

Insomnia

Psychosis

First Episode Psychosis

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.

They will be given the option of additionally participating in semi-structured interviews
prior to and after using the intervention, to talk about their expectations and
experiences of Sleepio. Service user participants will not be randomized to treatment.
All service user participants will be provided with access to Sleepio. Research will
focus on developing a model for the implementation of this intervention.

Keyworkers will be introduced to and supported in their role in referring service users
to the study and monitoring use of Sleepio through presentations, psychosocial
supervision, and reflection sessions. Keyworkers will be provided with an easy read
information sheet which clarifies their role as clinicians (attending a session to
reflect on their caseload and service user suitability for the study and providing
suitable service users with information about the study) and potentially as research
participants (in semi-structured interviews) via email and letter. They will be given the
opportunity to ask questions and will be encouraged to speak to others about their
potential interview participation (such as their colleagues). They will provide written
consent if they wish to participate in semi-structured interviews, to talk about their
expectations and experiences of Sleepio use in Esteem.

Primary outcomes comprise implementation data and qualitative data concerning the
perspectives of clinicians and service users, which inform the resulting logic model.
Secondary outcome data comprises insomnia severity (Insomnia Severity Index), mental
health symptomatology (Depression Anxiety and Stress Scales; The Revised Green et al.,
Paranoid Thoughts Scale (R-GPTS); Specific Psychotic Experiences Questionnaire (SPEQ) -
Hallucinations Subscale) and worry about Covid19 (Fear of Covid19 Scale).

Sleepio

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

Rates of consenting and nonconsenting interested participants

Number of eligible vs. ineligible participants and reasons for ineligibility

Participant completion of measures assessment appointments and measures (ISI measure of
insomnia severity, DASS-21 measure of mental wellbeing, R-GPTS measure of paranoia, SPEQ
measure of hallucination, and Fear of Covid19). This outcome records whether or not these
were completed by participants, whereas secondary outcomes 6-10 examine participant
scores on these measures.

Measures attrition from intervention by recording how many sessions of intervention were
completed by participant.

Service user and clinician expectations and experiences of digital CBT-I intervention

As measured by the Insomnia Severity Index (ISI). Possible scores range from 0 to 28 and
higher scores indicate more severe insomnia.

As measured by the Depression, Anxiety and Stress Scales (DASS-21). Possible scores range
from 0 to 126 and higher scores indicate more psychological distress. The maximum score
on each subscale (depression, anxiety, stress) is 42.

As measured by the Revised Green et al., Paranoid Thoughts Scale (R-GPTS). Possible
scores range from 0 to 72 and higher scores indicate more severe paranoia.

As measured by the Specific Psychotic Experiences Questionnaire (SPEQ) - Hallucinations
subscale. Possible scores range from 0 to 45 and higher scores indicate more severe
hallucinatory experience.

As measured by the Fear of Covid19 Scale. Possible scores range from 7 to 35 and higher
scores indicate more fear of Covid19.

Participants using the Sleepio application - access for 6 sessions, over 10 weeks

Implementation of Digital CBT for Insomnia in First Episode Psychosis

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status