Implementation of a Digital Cognitive Behavioural Therapy Intervention for Insomnia in First Episode Psychosis in the Context of Covid19: A Mixed Methods Study
Phase: NA
Conditions: Insomnia, Psychosis, First Episode Psychosis
Sponsor: NHS Greater Glasgow and Clyde

 
 
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1. FULL TITLE  
Implementation of a Digital Cognitive Behavioural Therapy Intervention for Insomnia in 
First Episode Psychosis in the Context of Covid-19: A Mixed Methods Study  
2. TRIAL INFORMATION  
Trial Identifiers  
REC ID 
280858 
REC reference 
21/WS/0010 
Clinicaltrials.gov registration 
TBC – will be registered 
Protocol Version Number 
5.1 
Date 
12.03.2021 
 
Sponsor: 
Name 
NHS Greater Glasgow & Clyde 
Representative is Dr Colette Montgomery 
Sardar acting on behalf of NHS GGC 
Address of Sponsor Representative 
College of Medical, Veterinary and Life 
Sciences 
University of Glasgow 
Room 327, Wolfson Medical School 
Building 
University Avenue 
Glasgow, G12 8QQ 
Telephone (Sponsor Representative) 
0141 330 5097 
Email (Sponsor Representative) 
colette.montgomerysardar@glasgow.ac.u
k 
 
Chief Investigator:  
Name 
Prof. Andrew Gumley 
Address 
Mental Health and Wellbeing, 
Administration Building, Gartnavel Royal 
Hospital, Glasgow, G12 0XH 
Telephone 
+44 (0)141 211 3939 
Email 
Andrew.Gumley@glasgow.ac.uk 
 
Co-Investigator(s) 
Name 
Dr Fiona Robb 
Role/Position 
Lead Researcher/Trainee Clinical 
Psychologist 
 

 
 
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Address 
Mental Health and Wellbeing, 
Administration Building, Gartnavel Royal 
Hospital, Glasgow, G12 0XH 
Telephone 
+44 (0)141 201 9239 
Email 
0702839m@student.gla.ac.uk 
 
Name 
Dr Mairi Spanswick 
Role/Position 
Lead Field Researcher/Principal Clinical 
Psychologist 
Address 
Esteem North, Nevis Building, Stobhill 
Hospital, 133 Balornock Road, Glasgow, 
G21 3UW 
Telephone 
+44 (0)141 531 3207 
Email 
Mairi.Spanswick@ggc.scot.nhs.uk 
 
Name 
Dr Louise Beattie 
Role/Position 
Researcher/ Postdoctoral Researcher 
Address 
Mental Health and Wellbeing, 
Administration Building, Gartnavel Royal 
Hospital, Glasgow, G12 0XH 
Telephone 
+44 (0)141 211 3939 
Email 
Louise.Beattie@glasgow.ac.uk 
 
Research Collaborators: 
Name 
Prof. Colin Espie 
Role/Position 
Researcher/ Clinical Director, The Oxford 
Online Programme in Sleep Medicine; 
Senior Clinical Research Fellow, 
Department of Psychiatry, University of 
Oxford; Emeritus Professor of Clinical 
Psychology, University of Glasgow; Co-
Founder and Chief Medical Officer, Big 
Health 
Address 
Nuffield Department of Clinical 
Neurosciences. Level 6, West Wing, John 
Radcliffe Hospital, Oxford OX3 9DU 
Telephone 
+44 (0)1865 618661 
Email 
colin.espie@ndcn.ox.ac.uk 
 
 
Name 
Dr Alasdair L. Henry 
Role/Position 
Research Manager, Big Health Inc 
 
 

 
 
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Address 
Sleep and Circadian Neuroscience 
Institute, Nuffield Department of Clinical 
Neurosciences. Level 6, West Wing, John 
Radcliffe Hospital, University of Oxford 
OX3 9DU 
Telephone 
+44 (0)1865 234829 
Email 
alasdair.henry@bighealth.com  
 
 
Name 
Dr Christopher Miller 
Role/Position 
Honorary Senior Research Fellow and 
Research Lead, Big Health Inc 
Address 
Sleep and Circadian Neuroscience 
Institute, Nuffield Department of Clinical 
Neurosciences. Level 6, West Wing, John 
Radcliffe Hospital, University of Oxford 
OX3 9DU 
Telephone 
+44 (0)1865 234829 
Email 
chris.miller@bighealth.com 
 
Study Synopsis: 
Study Title 
Implementation of a Digital Cognitive Behavioural 
Therapy Intervention for Insomnia in First Episode 
Psychosis in the Context of Covid-19: A Mixed 
Methods Study 
 
Protocol Short Title/ 
Acronym: 
Implementation of a digital Cognitive Behavioural 
Therapy intervention for Insomnia in a first episode 
of psychosis  
Study Phase If Not Mentioned 
in Title 
Implementation study 
Sponsor Name 
NHS Greater Glasgow and Clyde  
Chief Investigator 
Prof Andrew Gumley 
Clinicaltrials.gov registration 
TBC – in progress 
REC Number 
21/WS/0010 
Medical Condition or Disease  Psychosis (first episode) 
Purpose of Research 
The aim of this project is to develop a logic model 
for the implementation of a digital Cognitive 
Behavioural Therapy for Insomnia, ‘Sleepio’, in 
people recovering from a first episode of psychosis. 
This implementation is placed in the context of 
Covid-19 restrictions and their aftermath. 
Primary Objective 
Development of a logic model 

 
 
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Secondary Objective(s) 
i)  Assess the implementation of Sleepio 
ii) Gather measures of symptomatology at baseline 
and post-intervention 
iii) Ascertain staff and service user expectations 
and experience of Sleepio 
Study Design 
Mixed methods implementation study 
Endpoints 
Saturation 
Sample Size 
~8 service users, <10 keyworkers 
Summary of Eligibility Criteria 
(service users) 
Inclusion:  
1. Service users under the care of Esteem First 
Episode Psychosis Service in NHS GGC 
2. Aged >=16yrs and ≤35 years (the service 
serves individuals between these ages) 
3. Potentially affected by Insomnia Disorder 
(defined by SCI-02 score ≤2) 
4. Access to a device to use Sleepio 
Exclusion:  
1.  Moderate to severe learning disability 
2. Acute Psychosis (recent crisis contact or 
hospitalisation) 
3. Incapacity to provide informed consent 
4. Insufficient English to access intervention 
5. Organic impairment 
6. No access to a device to use Sleepio 
 
Summary of Eligibility Criteria 
(staff) 
Inclusion:  
1. Holds position of Keyworker in Esteem First 
Episode Psychosis Service in NHS GGC 
Intervention (Description, 
frequency, details of delivery) 
Sleepio is a digital Cognitive Behavioural Therapy 
(CBT) application which is responsive to input data 
(Espie et al., 2012). It is composed of six 20-minute 
sessions presented by an animated therapist, which 
are unlocked weekly. It can be accessed via browser 
or iOS smartphone. Participants complete an initial 
assessment on a browser and chose a treatment 
goal, which drives personalisation.  
Sleepio’s components are those common to CBTi 
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) 

 
 
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behavioural components including sleep restriction, 
stimulus control, and relaxation techniques.   
Participants are prompted to complete planned 
sessions and enter sleep data. Sleepio’s algorithm 
tailors ongoing intervention based on this data and 
information about participants’ physical and mental 
health. Sleepio also provides access to online 
psychoeducation and a moderated user forum. 
Keyworkers will have access to the Sleepio online 
‘Sleep Clinic’, which allows them to monitor their 
service users’ use of the application and their 
reported sleep. Other users of the Sleep Clinic 
cannot see these individuals’ data.  
Comparator Intervention 
N/A.  
Maximum Duration of Treatment 10 weeks 
Version and Date of Final 
Protocol 
V5; 12.03.2021 
  
 
 

 
 
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3. ABSTRACT  
Background: Covid-19 lockdown regulations impact negatively on sleep and mental 
health. These impacts disproportionately affect individuals with pre-existing mental health 
difficulties. Sleep disorders, particularly insomnia, are common in first episode psychosis 
(FEP) and are associated with increased symptomatology. Mood and worry mediate the 
relationship between sleep and psychosis symptomatology. Cognitive Behavioural 
Therapy is effective in treating insomnia (CBTi). Pilot research suggests that insomnia is 
a tractable clinical target in psychosis. Digital CBTi (dCBTi) reduces both insomnia and 
paranoia, offering a non-contact intervention during Covid-19 lockdown and its aftermath.  
Aims: To inform the development of a logic model to support dCBTi (Sleepio) 
implementation in FEP services.  
Methods: People experiencing a FEP and Insomnia will be eligible to access Sleepio. 
Usage data will be collated. Symptomatology measures will examine changes in service 
user psychosis, insomnia, and mood symptomatology, and Covid-19-related worry at 
baseline and post-intervention. Service users and keyworkers will be invited to participate 
in semi-structured interviews to elicit their views of Sleepio implementation. We will 
summarise implementation data and describe changes in psychosis, insomnia, mood, 
Covid-19-related worry, and the relationships between these. A framework analysis will 
be used to analyse themes arising from interviews.  
Impact: We aim to develop a logic model to support future implementation of Sleepio in 
FEP services.  
 
 

 
 
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4. BACKGROUND AND RATIONALE 
 
4.1 The Context of Covid-19 
Following the emergence of severe acute respiratory syndrome Coronavirus 19 (Covid-
19), UK governments introduced regulations in order to protect public health. In Scotland, 
the Health Protection (Coronavirus) (Restrictions) (Scotland) Regulations 2020 
implemented measures to prevent, control and mitigate the spread of infection (Scottish 
Government, 2020a). These included requirements for individuals to have contact only 
with those in their household, stay 2 metres apart from others, and only leave home for 
approved reasons. Potentially infected individuals were required to quarantine. These 
regulations are planned to change in a phase-based approach in concordance with the 
prevalence of Covid-19 in the Scottish population. The Coronavirus Scotland Act 
amended the responsibilities of health and social care organisations to the populations 
they serve (Scottish Government, 2020b). The presence of Covid-19, quarantine, 
restrictions to normal life and impacts on health and social care provision bring challenges 
to population mental health.  
 
4.2 Mental Health during Pandemic 
Quarantine and physical distancing measures in response to pandemics impact on the 
psychological health of the population (Brooks et al., 2020; Hossain, Sultana & Purohit, 
2020). Systematic reviews suggest regulations raise the incidence of insomnia, low mood, 
post-traumatic stress (PTSD), avoidance of other people and of illness symptoms (e.g. 
coughs or sneezes; Brooks et al., 2020; Hossain et al., 2020). Research emerging from 
the Covid-19 pandemic in China and Italy (both of which imposed population-wide 
quarantine) has found increased anxiety and depression symptoms, poor sleep quality, 
and general psychological distress (Casagrande et al., 2020; Yan & Huang, 2020). In 
China, the prevalence of insomnia has increased significantly during lockdown, to almost 
1/3rd of those studied (Lin et al 2020). In Italy, anxiety, poor sleep, and psychological 
distress were together predictive of Covid-19-related PTSD symptomatology 
(Casagrande et al., 2020). Morrin and Carrier (2020) have suggested that there is a high 
rate of acute insomnia associated with Covid-19 in the general population, with a risk of 
an ongoing increase in the prevalence of chronic insomnia. In Scotland, Covid-19 is 
anticipated to reduce psychological wellbeing and increase sleep disorder, particularly in 
those with pre-existing mental health difficulties (Public Health Scotland, 2020). There is 
an opportunity and need for appropriate interventions, which can be delivered within the 
current context. 
 

 
 
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4.3 Pre-Existing Mental Health Conditions 
Particular subpopulations are likely to be disproportionately affected by the psychological 
impacts of Covid-19; such as those who live in deprived areas, the elderly, people with 
disabilities, and people with pre-existing mental health conditions. Previous mental illness 
diagnosis, higher fear of infection, being a healthcare worker, loss of routine, and lack of 
supplies access are associated with worse psychological outcomes during pandemics 
(Brooks et al., 2020). Pre-existing mental health conditions have been shown to be a risk 
factor for poorer psychological outcomes during Covid-19 lockdown regulations 
specifically (Li et al., 2020). People recovering from a first episode of psychosis (FEP) are 
one such group. This population typically present with mental, physical and social 
comorbidities (Gates et al., 2015), which may further increase their vulnerability to 
distress (Wright, Steptoe and Fancourt, 2020).    
 
4.4 Sleep Disorder in Psychosis 
As above, several reviews suggest that pandemics and Covid-19 specifically impact on 
sleep, particularly in raising the incidence of insomnia (Brooks et al., 2020; Hossain et al., 
2020; Casagrande et al., 2020; Yan & Huang, 2020). Sleep disorders are common in 
persons affected by psychosis outwith the context of a pandemic (Reeve, Sheaves & 
Freeman, 2015; Laskemoen et al., 2019). Common presentations include Insomnia 
(~50% Freeman et al., 2019; Laskemoen et al., 2019 Freeman et al., 2009; Palmese et 
al., 2011), Nightmare Disorder (~50%, Sheaves, Onwumere, Keen, Stahl, & Kuipers, 
2015), Sleep Apnea (Sharafkhaneh et al., 2005) and Hypersomnia (~30% Laskemoen et 
al., 2019; Hawley et al., 2010). Sleep disorders are prevalent at early and first episode 
stages of psychosis (~80% have at least one Sleep Disorder, Davies et al., 2017; Ma et 
al., 2018; Reeve, Sheaves & Freeman, 2018a; Reeve et al., 2019b).  
Insomnia Disorder is a clinically significant difficulty in initiating or maintaining sleep. 
Insomnia is the best recognised and most studied sleep disorder in people affected by 
psychosis. The estimated prevalence of insomnia in those experiencing a first episode of 
psychosis is ~50% (Reeve et al., 2015; Davies et al., 2017; Reeve, Sheaves & Freeman, 
2018a). In this population, sleep disorder is highly comorbid, with most individuals 
experiencing three or more sleep disorders (Reeve et al., 2019).  
 
4.5. Insomnia and Psychosis Symptomatology 
Sleep disorder has been explored as a contributing and causal factor in experiences of 
psychosis (Harvey et al., 2011). In the general population, sleep disorder is related to 
psychosis-like experiences, such as auditory hallucinations (Koyanagi & Stickley, 2015). 
In people affected by psychosis, severity of sleep disorder is related to flattened affect, 

 
 
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increased hallucinations, cognitive disorganisation, and paranoia, and poor clinical 
outcomes (Afonso et al., 2014; Taylor et al., 2015; Davies et al., 2017; Hou et al., 2017; 
Kilicaslan et al., 2017; Li et al., 2017; Chung et al., 2018; Reeve et al., 2018a; Villa et al., 
2018; Reeve et al., 2018b). In a first episode inpatient group, Subramaniam et al (2018) 
found that insomnia was associated with reduced quality of life. In people at ultra-high-
risk of psychosis, sleep disruption has been associated with positive and negative 
symptoms (Lunsford-Avery et al., 2015; Poe et al., 2017), disrupted cognitive functioning 
(Lunsford-Avery et al., 2017), severity of psychotic experiences such as hallucinations 
and delusions (Reeve et al., 2019a), and overall functioning (Poe et al., 2017). In 
individuals affected by psychosis there is an interaction between sleep disorder, psychotic 
symptoms and medication status (Reeve, Sheaves & Freeman, 2015). Those who are 
medication naive or not taking medication experience different sleep disorders than those 
who are taking antipsychotic medications (Chouinard, Poulin, Stip, and Godbout, 2004).  
Whilst few studies have examined the relationship between sleep disorder and psychosis 
symptoms across time, sleep disorder does seem to predict psychotic experience (Reeve, 
Sheaves & Freeman, 2015). In the general population, sleep disorder predicts paranoia 
(Freeman et al., 2012; 2013). Insomnia in particular has been proposed to act as a 
mediator in psychosis (Dolsen, Asarnow & Harvey, 2014). Increased insomnia is related 
to increased paranoia (Freeman et al., 2011) and hallucinations (Sheaves et al., 2016). 
Insomnia is predictive of the persistence of psychosis symptomatology, specifically 
hallucinations (Reeve et al., 2018b). A high proportion of those who develop symptoms 
of psychosis report sleep disorder prior to this (~77%, Tang and Ang, 2001). Sleep-wake 
abnormalities predict symptomology in youth at high risk of developing psychosis 
(Lunsford-Avery, LeBourgeois, Gupta, & Mittal, 2015).  
It is currently not clear whether psychosis symptoms can lead to disordered sleep, 
however it is possible that the relationship is bidirectional (Reeve, Sheaves & Freeman, 
2015). Paranoia is known to increase insomnia, therefore suggesting that the relationship 
between insomnia and paranoia is bidirectional (Reeve et al., 2018b). 
 
4.6 The Role of Mood Disorder 
The interaction between insomnia and psychosis symptomatology is thought to be 
mediated by mood disorder. In the general population, the relationship between paranoia 
and sleep is partially mediated by depression and anxiety symptoms (Freeman et al., 
2009; 2011; Taylor et al., 2015). In psychosis populations, sleep disorder and psychosis 
symptomatology are related to mood (Reeve et al., 2018a; Villa et al 2018). In first episode 
populations, Reeve et al (2019) found patients with sleep disorders had more severe 
depression, and anxiety. 
Cognitive models of paranoia and persecutory delusions suggest that negative affect 
specifically may link sleep disorder and paranoia (Freeman et al., 2009). More recent 

 
 
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models suggest that anxiety, depression and worry contribute to the development of 
paranoia and sleep disorder, then paranoia is then heightened by insomnia (Freeman et 
al., 2009; Reeve, Sheaves & Freeman, 2015). More recently, Kasanova et al (2019) found 
that whilst poor sleep quality predicts paranoia in a psychosis population, this is fully 
mediated by negative affect.  
Mood is also a mediator of insomnia in the context of Covid-19. Higher Covid-19-related 
worry, depression symptoms and anxiety have been found to be associated with higher 
insomnia in Greece (Voitsidis et al., 2020). In France, Covid-19 related worry was found 
to be a major predictive factor for insomnia, in addition to previous mental illness 
diagnosis (Kokou-Kpolou et al 2020). Adverse experiences and worry have been shown 
to be together related to the development of poor sleep during the UK lockdown, which 
then impacted on mental health (Wright, Steptoe and Fancourt, 2020). In the current 
context of Covid-19, related worry and governmental regulations based on Covid-19, 
sleep may deteriorate in people affected by a first episode of psychosis, impacting on 
mood, psychosis symptomatology and other mental health variables. 
 
4.7 Intervention for Insomnia in Psychosis 
The relationship between sleep disorder and psychotic symptomatology has led to 
exploration of sleep as a primary therapeutic intervention target (Freeman et al., 2015; 
Waite et al., 2020). Current DSM-V guidelines suggest that clinically significant sleep 
disorder should receive clinical input, regardless of the presence of psychosis (APA, 
2013).  Additionally, patients with psychosis highlight a preference for intervention around 
sleep disorder as part of overall treatment (Waite et al., 2015). Intervention around sleep 
also presents the opportunity for a low-stigma intervention in a population who experience 
high levels of stigma (Freeman et al 2017). 
Insomnia is a tractable clinical target in this population, for which intervention shows 
promising results. Cognitive Behavioural Therapy has been shown to be effective in 
treating insomnia in non-psychosis populations (CBTi; Mitchell et al., 2012; Trauer et al., 
2015). A case series study demonstrated large reductions in insomnia symptoms and 
persecutory delusions, and reductions in anxiety, depression and anomalous experience 
following CBTi (Freeman et al., 2015; Myers, Startup & Freeman, 2011). A large single-
blind RCT of CBTi in outpatients experiencing psychosis found the intervention was 
effective in reducing insomnia in this population, with large effect sizes, but was 
inconclusive regarding impacts on psychosis symptomatology (Freeman et al., 2015). 
Chiu et al (2018) examined the use of CBTi in addition to treatment as usual in people 
affected by psychosis and found that the greatest improvement in sleep was observed in 
those persons who experienced ‘classic’ severe insomnia. 
Whilst CBTi is effective, there are concerns about whether it can be scaled to meet the 
need in the general population affected by psychosis or in specific populations such as 
those experiencing an FEP, given the prevalence of insomnia (Espie, 2009; Reeve et al., 

 
 
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2018). In the current context, there is an opportunity and need for digital psychological 
interventions, delivered remotely. Internet-delivered CBTi is effective in improving sleep 
in adults with insomnia (Seyffert et al 2016). Digital CBTi application, Sleepio, reduces 
insomnia in non-clinical populations, with a comparative efficacy to 1-1 input (Espie et al., 
2012). Sleepio has been shown to reduce insomnia, hallucinations and paranoia in a large 
non-clinical population (Freeman et al., 2017). In this study, change in insomnia was 
responsible for ~60% of the variance in participants’ paranoia. Additionally, digital 
application-based interventions have been increasingly used in FEP populations (Rus-
Calafell & Schneider, 2020).   
 
4.8. Why is this research needed? 
Sleepio therefore provides a psychotherapeutic intervention which can be offered 
remotely in the current context of Covid-19. This intervention targets Insomnia - one of 
the most common comorbid difficulties in FEP, a common psychological impact of 
pandemic-related regulations - and may also demonstrate effects on wider psychological 
wellbeing in this population. 
Sleep disorder in psychosis is a complex problem, affected by interacting psychological, 
social, and biological factors (such as sleep beliefs, quality of living situation, and 
physiological arousal). We therefore intend to study the implementation of the Sleepio 
intervention through the lens of the Medical Research Council Complex Interventions 
Framework (Moore et al., 2015). The proposed work aims to collect data to build a model 
of digital CBTi implementation in NHS Greater Glasgow and Clyde Esteem FEP services, 
based on this framework.  
 
 
 
 

 
 
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5. AIMS AND OBJECTIVES 
 
Informed by the Medical Research Council MRC complex interventions process 
evaluation framework (Moore et al., 2015); we aim to develop a logic model of Sleepio 
implementation in people recovering from FEP, in the context of Covid-19 restrictions and 
their aftermath. 
We will assess: 
5.1. Implementation  
1) What is the rate of ineligibility and why?  
2) What is the rate of consent into the study?  
3) Can we characterise participant sleep disorder? 
4) Do participants complete Sleepio initial assessment?  
5) Do participants enter daily and weekly data? 
6) How many sessions do participants complete? 
7) What is the rate of attrition from intervention? 
 
5.2. Symptomatology Measures 
At baseline and post-intervention: 
1) What are the characteristics of participants’ insomnia? 
2) What are the characteristics of participants’ psychotic symptomatology? 
3) What are the characteristics of participants’ mood? 
4) What are the characteristics of participants/ Covid-19-related worry? 
 
5) What is the relationship between insomnia, psychosis symptoms, mood and 
Covid-19 related worry? 
 
5.3. Staff and Service User Expectations 
1) What are staff expectations of Sleepio implementation? 
2) What are service user expectations of Sleepio implementation? 
3) How do staff and service user views compare and contrast?  
 
5.4. Staff and Service User Experiences 
1) What are staff experiences of Sleepio implementation? 
2) What are service user experiences of Sleepio implementation? 

 
 
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3) How do staff and service user views compare and contrast?  
5.5. Logic Model 
 
 
Figure 1. Key functions of process evaluation and relations among them from MRC Complex 
Interventions guidance. 
From these data, we aim to develop a logic model for the implementation of Sleepio 
intervention in FEP services. This model will graphically represent the hypothesized 
context, the process of implementing Sleepio, the mechanisms of its impact, outcomes of 
Sleepio and other factors acting upon this (Moore et al., 2015). 
 
 
 
 

 
 
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6. METHOD 
 
6.1 Study Design 
The proposed study is a mixed methods implementation study of the dCBTi application 
‘Sleepio’ in the context of the Esteem First Episode of Psychosis service in NHS Greater 
Glasgow and Clyde. We plan to record data about the profile of sleep disorders, uptake 
and usage of Sleepio, complete pre- and post-intervention symptomatology measures 
with participating service users, and undertake qualitative interviews with keyworkers and 
service users. The primary aim is to characterise the implementation of Sleepio by 
integrating these data into a logic model.  
  
6.2 Setting 
The study will take place within the NHS Greater Glasgow and Clyde (NHS GGC) First 
Episode Psychosis (FEP) Service, ‘Esteem’. This service has two teams – one covering 
the North of the city and one covering the South and Inverclyde areas.  
 
6.3  Participants 
This study utilizes two groups of participants: 
6.3.1 Service users of Esteem  
6.3.2 Esteem keyworkers  
 
6.4  Inclusion and Exclusion Criteria 
6.4.1 Inclusion and exclusion criteria for service user participants:  
64.1.1 Inclusion criteria  
i. 
Service users under the care of Esteem First Episode Psychosis Service in 
NHS GGC 
ii. 
Aged >=16yrs and <=35 years (the service sees individuals between these 
ages) 
iii. 
Potentially affected by Insomnia Disorder (defined by SCI-02 score ≤2) 
iv. 
Who have access to a device they can use Sleepio on (a computer device 
with Safari or Google Chrome browser, or an iPhone device). 
 
6.4.2.1 Exclusion Criteria 

 
 
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i. 
Moderate to severe learning disability 
ii. 
Acute Psychosis (recent crisis contact or hospitalisation) 
iii. 
Incapacity to provide informed consent 
iv. 
Insufficient English to access intervention 
v. 
Organic impairment 
vi. 
No access to a device which can be used for Sleepio intervention.  
 
6.4.2 Inclusion and exclusion criteria for keyworker participants:  
6.4.2.1 Inclusion criteria  
i. 
Holds position of Keyworker in Esteem 
 
6.5 Intervention 
This study provides service users of Esteem with access to a digital CBTi application, 
‘Sleepio’. It aims to model factors of the implementation of this intervention in FEP 
services in NHS Scotland. Service user participants will be asked to continue to engage 
with their treatment as usual whilst accessing Sleepio. Esteem keyworkers will be 
involved in providing information and referral to the study for service users with sleep 
difficulties, then supporting service users’ use of the intervention through the ‘Sleep Clinic’ 
online interface. 
6.5.1 Treatment as Usual (TAU) 
Esteem provides multidisciplinary input over a two-year timeline to those affected by a 
FEP. Treatment may consist of different therapies determined by clinical need. Treatment 
will include regular contact with a care coordinator (“keyworker”), medication 
management by a Psychiatrist and access to psychosocial interventions (e.g. 
psychological therapy or occupational therapy), as considered appropriate by the clinical 
team. Esteem clinicians conduct routine enquiry about sleep difficulties and may provide 
psychoeducation about sleep improvement as part of TAU. TAU will be free to vary for 
service user participants in the study. 
6.5.2 Sleepio 
Participating service users will receive access to a comprehensive sleep assessment 
carried out by researcher FR and to the Sleepio intervention. Sleepio is a dCBTi 
application which is personalised in response to input data (Espie et al., 2012). Sleepio’s 
components are those common to CBTi 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 

 
 
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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. Sleepio can be 
accessed via web browser (Safari or Google Chrome) or iOS smartphone. It cannot 
currently be accessed using an Android smartphone.  
Keyworkers will be asked to monitor service users’ progress with using the Sleepio 
application. They will be provided with access to the ‘Sleep Clinic’ in order to support this 
role.  The Sleepio Sleep Clinic is an online platform where health professionals can 
observe completion, data entered and Sleep Condition Indicator scores for service users 
they have clinical responsibility for. Service users will be made aware of keyworker 
access to this, prior to consenting to participate.  
 
6.6 Recruitment and Consent 
6.6.1. Sample Size 
6.6.1.1 Service Users 
The Esteem population includes ~250 service users, with ~150 new users per year. 
Around 80% would be expected to experience clinically significant sleep difficulties 
(~200/250) and around 50% to experience Insomnia Disorder (~125/250; Reeve et al., 
2018a). It is difficult to estimate the rate of eligible persons who will be willing to participate 
and will be retained in the study. A sample of ~8 for use of the Sleepio intervention has 
been considered feasible in terms of study resource. Sample size throughout (e.g. 
recruitment, withdrawal, participation in follow-up) will act as implementation data. As the 
study is not designed to identify change in symptomatology measures, power calculations 
have not been carried out. We aim to recruit ~5 service users to participate in optional 
interviews.  
6.6.1.2 Keyworkers 
There are approximately 20 clinicians working as keyworkers in Esteem. We aim to recruit 
~10 to interview.  
6.6.2. Integration into the Esteem Service 
Esteem are strongly in support of the project and are agreeable to their planned level of 
involvement in recruitment and monitoring. Evidence of management approval will be 
supplied.  Two of the research applicants (AG and MS) work clinically in these services. 

 
 
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We plan to continue to present the study to the clinical staff teams and demonstrate the 
Sleepio application and Sleepio Clinic, in order to ensure keyworker familiarity and 
support for the project. Applicant MS provides supervision to keyworkers in Esteem for 
low intensity psychosocial interventions. Through this, she intends to support sleep 
enquiry and monitoring service user participants’ use of Sleepio. Keyworkers will be 
provided with information about the study and their role as clinicians and as research 
subjects. We will offer an appointment with each keyworker to reflect upon their caseload 
and consider service users who may be appropriate to access the study and intervention.  
6.6.3. Recruitment and Consent Procedures 
6.6.3.1 Service Users 
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 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.  
6.6.3.2 Keyworkers 
As above, 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 

 
 
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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.  
6.6.4 Randomisation 
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. 
 
6.7 Data Collection 
6.7.1 Implementation Data  
We will gather data on eligibility, consent rates and the rate of service user participants 
beginning intervention. We will gather data on clinical sleep disorder assessment 
outcomes. Sleepio intervention will span week 0 to week 10. Usage data will be collated 
throughout these 10 weeks via the application. This data will comprise the rate of 
completion of the six sessions contained in the intervention and of sleep diaries. These 
metrics will allow us to ascertain intervention adherence, attrition and completion. We will 
further record rates of attendance to complete symptomatology measures. In analysis, 
these data will be represented by rates and summary statistics.  
6.7.2 Measures 
Symptomatology measures will be completed with service user participants using NHS 
Attend Anywhere or at in-person appointments at baseline (week –1), and at week 11. 
Researchers completing these appointments are NHS GGC employees with pre-existing 
access to Attend Anywhere. We will complete symptomatology measures using Online 
Surveys (https://www.onlinesurveys.ac.uk/; formally Bristol Online Surveys). Online 
Surveys is UK based, Data Protection Act 2018-compliant and has ISO certification. If 
sessions are undertaken in person, these measures will be completed on paper. The 
study researchers are not aware of any issues in relation to the suitability, ease of use or 
acceptability of these measures in this service user group.  The baseline appointment will 
also allow participants to set up the Sleepio application and complete its initial 
assessment.  
Service user participants will be assessed with measures of: 
6.7.2.1 Insomnia 
Service users will be screened for insomnia after completing consenting procedures, 
using the Sleep Condition Indicator – 2 Item (SCI-02; Luik et al, 2019). This is a reliable 
and validated shortened screening measure for insomnia, which correlates well to full 

 
 
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insomnia measures. Service users who’s scores are not indicative of insomnia will be 
ineligible for study participation.  
Insomnia symptoms will be assessed using the Insomnia Severity Index (Bastien, 
Vallieres, and Morin 2001) at baseline and week 11. This is a brief self-report 
questionnaire, designed to assess the severity of nighttime and daytime components of 
insomnia. It is widely used, demonstrates good reliability and validity, and is responsive 
to change through clinical treatment. 
Additionally, participants will be regularly prompted within the Sleepio intervention to 
complete the full Sleep Condition Indicator (SCI, Espie et al., 2012). SCI is an 8-item scale 
which measures sleep problems against DSM-5 criteria for Insomnia Disorder. It has good 
validity and reliability and is sensitive to change (Espie et al., 2014). These scores will be 
available for analysis by researchers.  
6.7.2.2 Mental Health Symptomatology  
Psychotic symptoms will be assessed using the Specific Psychotic Experiences 
Questionnaire; hallucinations subscale (SPEQ(H), Ronald et al., 2014) and Revised 
Green et al Paranoid Thought Scales (R-GPTS, Freeman et al., 2019). The SPEQ is a 
transdiagnostic self-report measure of psychosis symptomatology, which comprises 
subscales of paranoia, hallucinations, cognitive disorganization, grandiosity, anhedonia, 
and parent-rated negative symptoms. The R-GPTS is a two-factor measure of paranoid 
thoughts, with subscales distinguishing persecutory ideation and ideas of social 
reference. 
Mood symptoms will be assessed using the Depression, Anxiety and Stress Scales 21 
item (DASS-21, Lovibond and Lovibond, 1995; Anthony et al., 1998). The DASS-21 is a 
widely used measure assessing symptoms of depression (low positive affect, low self-
esteem, hopelessness), anxiety (physiological symptoms, situational anxiety), and stress 
(negative affect, tension, agitation).  
Covid19 worry will be assessed using the Fear of Covid19 Scale (Ahorsu et al., 2020). 
This scale is new but has relatively good metrics and has been validated in several 
populations. 
 
6.7.3 Qualitative Interviews 
6.7.3.1 Service Users 
Service users will be provided with the option to participate in semi-structured interviews 
prior to beginning intervention and/or after completing the intervention. Each interview 
appointment will last ~45 - 60 minutes. Pre-intervention interviews will be undertaken prior 
to the baseline symptomatology measures appointment, at approximately week -2. They 
will focus on service users’ expectations for the Sleepio intervention (see Interview 
Schedule).  

 
 
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Post-intervention 
interviews 
will 
be 
undertaken 
after 
completing 
follow-up 
symptomatology measures, at approximately week 12. They will focus on service users’ 
experiences of the Sleepio intervention (see Interview Schedule). Post-intervention, 
participants will be purposively sampled to include a range of service users reflecting their 
engagement with the Sleepio App.  
Interviews will be undertaken using a NHS Microsoft Teams meeting from an NHS GGC 
computer or in-person at an Esteem base. Attend Anywhere cannot be used as it is not 
possible to record on this platform. As with Attend Anywhere, researchers have pre-
existing access to this as NHS GGC employees and it is considered secure for NHS use. 
Interviews will be digitally video recorded and auto-transcribed for purposes of analysis. 
These are inbuilt features of Microsoft Teams meetings. If interviews take place in person, 
data will be collected in the form of audio recordings on an encrypted recording device 
and transcribed by researcher FR. 
Service users can participate in pre- or post-intervention interviews, or neither.  
6.7.3.2 Keyworkers 
Keyworkers in Esteem will be offered the opportunity to participate in semi-structured 
interviews prior to service users beginning intervention and/or after all service users have 
completed the intervention. Each interview appointment will last ~45 - 60 minutes. Pre-
intervention interviews will focus on keyworkers’ expectations for the Sleepio intervention 
(see Interview Schedule).  
Post-intervention interviews will focus on keyworkers’ experiences of the Sleepio 
intervention use in Esteem (see Interview Schedule).  
Interviews will be undertaken using a NHS Microsoft Teams meeting from an NHS GGC 
computer or in-person at an Esteem base. As above, interviews will be digitally video or 
audio recorded and transcribed for purposes of analysis.  
Keyworkers can participate in pre- or post-intervention interviews, or neither.  
 
6.8 Participant Withdrawal 
All participants will have the right to withdraw from the study at any time. It will be clearly 
stipulated at the time of consent that they have this right and that withdrawal will not affect 
their clinical treatment (service users) or role in Esteem (keyworker participants).  
Withdrawal from the study can be at the request of the participant or at the discretion of 
the researchers. Withdrawn participants will be informed that they will no longer continue 
with the study protocol and that their withdrawal from the study will not influence their 
treatment/role within the service. Research data collected up to the time of withdrawal 
against anonymous participant IDs or Sleepio access IDs will be retained for use in the 
study.  Video or audio recordings collected up to the time of withdrawal will be retained 

 
 
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for use in the study and transcription. Consent forms will be retained. Other non-
anonymized or personal data will be destroyed should a participant withdraw from the 
study. All of this is made clear to interested persons prior to consenting to participate.  
Service user participants may also choose to stop using the Sleepio intervention, without 
withdrawing from the study. These participants would still be asked to participate in the 
post-intervention assessment session and be given the option of participating in post-
intervention interviews. This will be made clear to interested persons prior to consenting 
in the Participant Information Sheet.  
The sponsor reserves the right to terminate the study at any stage for any reason, 
including funding considerations. Existing participants will be informed of the termination 
of the study and will be followed-up as part of their TAU clinical management. 
 
6.9. Statistical Analysis 
The main aim of the implementation study will be delivered via the development of a 
logic model describing the potential implementation of Sleepio within FEP services in 
NHS Scotland.  
6.9.1. Quantitative 
Descriptive quantitative information will be provided for implementation measures 
(percentages, rates, mean, median, variance, 95% confidence intervals). This will include 
reporting data on attrition rates and loss to follow-up.  
Descriptive quantitative information will be provided for sleep assessment.  
Analyses of symptomatology measurements will not be focused on statistical significance 
but will be quantitatively detailed (estimated 95% confidence intervals, variance) to 
assess the likely range of treatment effects. Our study is not designed nor powered to 
detect statistical differences in measures over time. Exploratory analysis of the 
relationship between symptomatology variables will be undertaken.  
6.9.2. Qualitative 
Information arising from qualitative interviews will analysed using a framework analysis 
based on the MRC Complex Interventions framework.  
6.9.3. Modelling 
A logic model of Sleepio implementation in FEP services will be developed from 
quantitative and qualitative data.  
6.9.4. Other  
A timeline of changes to Scottish government regulations regarding Covid-19 will be 
collated in order to contextualize study data. 

 
 
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7. ETHICS, PROJECT AND DATA MANAGEMENT 
7.1 Ethics  
7.1.1 Ethics  
The proposed project will be conducted in compliance with the principles of the 
Declaration of Helsinki (1996), the principles of GCP and in accordance with the UK policy 
framework for health and social care research. 
7.1.2 Ethics Approval 
Esteem service managers have confirmed Esteem service capacity and capability to 
undertake the project (see Service Manager Approval – V1). We will apply for NHS GGC 
Research and Development (R&D) approval. We will seek ethical approval from the NHS 
Research Ethics Committee (REC). This protocol and related documents will be 
submitted for review. The study will request approval from NHSGGC Information 
Governance.  
FR will ensure that University of Glasgow Doctorate in Clinical Psychology Research 
Programme Lead ‘Proceed to Ethics’ letter, REC ‘Favourable Opinion’ and R&D approval 
are be in place before recruiting.  
7.1.3 Consent Processes 
Participation will not commence without informed consent, including ensuring participant 
awareness of confidentiality and limits to confidentiality. Consent will be taken by 
researcher FR. All study participants will be provided with a written information sheet and 
a written consent form for the study. All participants will have been judged to be capable 
of providing informed consent. It will be emphasised that potential participants may wish 
to contact others before making up their mind and that there is no hurry to decide. It will 
be made clear that study participation status will have no impact on TAU care or their role 
in Esteem.  
At an Attend Anywhere appointment, the researcher will talk the participant through the 
consent form, verbal consent will be sought and participants will be asked to initial and 
sign two copies of the consent form and return one. For service users this will be via pre-
addressed envelope, for keyworker participants this will be via scanning and email or pre-
paid envelope. One copy will be retained by the participant and the other by the research 
team. The copy retained by the research team will be scanned and stored electronically 
on University of Glasgow servers. The paper original will be destroyed.  
Aspects of the consent process will be optional, for example for service users to 
participate in interviews pre- and post-intervention. 
Potential service user participants will be made aware that the study may pose a risk of 
distress prior to consenting. Keyworkers will be informed of participating service users. 

 
 
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Participants will be made aware of who to contact should they experience distress and 
the limits of confidentiality if there is risk to the participant or other persons. 
 
7.2 Project Management 
AG will be responsible for monitoring all research procedures and will supervise 
researcher FR during the study. MS will act as field coordinator and supervisor during the 
study. FR and MS will be responsible for recruitment of service users and keyworkers. 
FR will be responsible for collection of measures, rates of consent, interviewing, data 
monitoring and management, analysis and report writing. MS will be responsible for staff 
training and supervision associated with the study and regarding sleep difficulties in FEP 
more generally (although contribution will be made by AG, LB and FR). Big Health Ltd 
(CE, AH and CM) will be responsible for providing Sleepio usage data. The research 
group (AG, MS, LB and FR) will meet bimonthly throughout the trial to monitor progress 
and achievements. 
NHS GGC Research and Development and the NHS Scotland Research Ethics 
Committee will establish the ethical standard of the study protocol.  AG will have the 
responsibility to fulfil all the research governance arrangements and liaise with the NHS. 
7.3 Data Management  
7.3.1 Data Collection 
Implementation, measures and interview data will be collected by the project researcher 
FR, under the supervision of AG and MS. Big Health Ltd will collate usage data for 
Sleepio. 
7.3.2 Data Management and Storage 
Please see the Data Protection Impact Assessment (V3 – 03.03.2021) for this study. 
Personally identifiable data will be held separately from research data, which will be 
paired with anonymous participant IDs. Interview recordings will be saved against 
participant IDs, although these do contain non-anonymised data as they are video 
recordings. Transcriptions will have personal or identifiable information removed and will 
be saved against participant IDs. 
Personal identifiable data (e.g. names, email addresses and telephone numbers) will be 
kept separately from research data and will be stored within NHS GGC premises and 
electronic servers. Interview video or audio recordings will be stored on NHS GGC 
servers. There will be a key which links participant IDs to personal identifiable data and 
participant IDs to Sleepio access codes. These will be stored separately from all research 
data, in locked folders in NHS GGC. These will never be stored in the University of 
Glasgow and can be accessed only by the lead researcher (Dr Fiona Robb) and chief 

 
 
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investigator (Prof Andrew Gumley).  Pseudonymized study data will not be identifiable 
without access to these anonymization keys. 
The study will hold and analyse pseudonymised data outwith NHS GGC (at the University 
of Glasgow) in locked storage and password protected electronic files. This data will be 
held in accordance with NHS GGC and University of Glasgow policies, the Data 
Protection Act and the Data Protection Act 2018. Core research team members are all 
contracted staff of the University of Glasgow and NHS Greater Glasgow and Clyde. All 
researchers are trained in and will be familiar with current laws, rules and protocol 
(governed by the NHS, university ethics guidelines and the Data Protection Act 2018) 
regarding consent, anonymity and data storage. 
No data will be sent from NHS GGC nor the University of Glasgow to Big Health. 
Pseudonymised usage data will be sent from Big Health to the University of Glasgow. 
The pseudonymized data will be labelled with the individual Sleepio access codes which 
researchers initially share with participants to enable them to access Sleepio for free.  The 
list of paired access codes, participant IDs and participant names will be stored within 
NHS GG&C only, not the University of Glasgow.  The pseudonymized data will not be 
identifiable without access to the anonymization keys. All data in the Sleepio system is 
encrypted both "in transit" and "at rest".  This means that the data is protected en-route 
from users’ computer to the Sleepio servers, and also protected once it reaches the final 
destination of the Sleepio servers. The research team will be provided with 
psuedonymized data assessed by Sleepio such as adherence to treatment, sleep diary, 
engagement and measures collected with the application. This will be shared using an 
encrypted file.  This data may be compared to other pseudonymized data, stored by 
participant ID but will never be paired with identifiable personal information.   
Personal identifiable data is captured directly by Sleepio and stored by Big Health Ltd as 
standard for users of its application (for example name, email address, age, sex). Big 
Health treat these data as confidential in line with appropriate UK, EU and US regulations 
for protecting data. This data is not collected for the purposes of this research. This data 
will not be transferred to the University of Glasgow and only pseudononymized data will 
be sent. Big Health Ltd retain this personal identifiable data for 5 years, after which it is 
deleted. App users can also request deletion of this data at an earlier time.  
Prior to providing consent to participating in the study, participants will be made fully 
aware of how their study data will be handled and who will have access to it. Only those 
in the core research team (AG, MS, LB, and FR) will have access to study research data.  
Following study completion, anonymized research data, consent forms and interview 
transcriptions will be held for 10 years, as per University of Glasgow policy. It will be 
stored in secure electronic folders and accessible only to the Chief Investigator.  
 
8. HEALTH AND SAFETY 

 
 
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8.1. Researcher Safety Issues 
Use of Attend Anywhere or Microsoft Teams in home environments may reveal 
researchers’ personal information. Researchers will ensure this is used in private spaces, 
will use blur background functions and will adhere to Esteem operational policy around 
its use.  
Recruitment, follow-up and data collection may require significant practical and emotional 
labour. Supervision and time-management skills will be used to manage this. Researcher 
availability and monitoring of inboxes will be made clear to participants to maintain 
boundaries.    
8.2. Participant Safety Issues 
Participant sample may be associated with impulsive, irrational or unpredictable 
behaviour, and/or poor emotional control. Service users will be considered for their 
suitability by their keyworker. Participating service users will be in active contact with 
services at the time of their participation. Prior to consenting, participants will be made 
aware that keyworkers will be informed of their participation and will be able to monitor 
their Sleepio usage and sleep diaries. Researchers have a duty of care to report 
significant risks to a participant or to others to the mental health team in the event of a 
disclosure. These limitations to confidentiality will be made clear during consent 
processes. Researchers will ensure that appointments are undertaken in private spaces. 
Symptomatology measures and Sleepio intervention may be associated with emotional 
distress. Use of this application is novel to this participant group and may cause distress, 
particularly in those affected by paranoia regarding technological devices. Potential 
participants will be made aware of the risk of distress prior to consenting.  
8.3 Adverse Events 
Any adverse events (as defined by HRA) will be reported to study sponsors and REC.  
We will record and consider serious adverse incidents, consistent with organizational 
policy. These are defined as deaths, life-threatening illness or injury, suicidal or non-
suicidal self-injury, serious violent incidents, admissions to hospital or units, any event 
which results in persistent or significant disability or incapacity, any event for which 
medical or surgical intervention required to prevent the above and any event otherwise 
considered medically significant by the Chief Investigator. We will also record adverse 
events, including but not limited to increased paranoia associated with using the Sleepio 
application. Additional events will be categorized by study researchers using their clinical 
judgement.  
In case of a serious adverse incident, the responsible clinical team and the ethics 
committee will be informed. Appropriate actions in response to events will be determined 
on a case by case basis. 
 

 
 
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9. FINANCIAL CONSIDERATIONS  
There will be no cost associated with Sleepio access for the purpose of this study.  
 
10. DISSEMINATION 
The planned project will be written-up to meet the requirements of a Doctorate in Clinical 
Psychology at the University of Glasgow. Additionally, we plan to disseminate our findings 
via publication in a peer-reviewed journal. AG and FR will submit a final report at 
conclusion of the study to the Sponsor(s). Results of the project will also be disseminated 
within the host service, Esteem. A plain language summary of project results will be 
disseminated to study participants.   
 
11. PRACTICAL APPLICATIONS 
Digital CBT intervention presents a psychological intervention that can be offered under 
current conditions and is likely to be efficacious. Exploration and treatment of sleep 
disorders are intended to become part of TAU care in NHS GGC FEP services. A logic 
model of Sleepio implementation will help inform this.  
 
12. PROJECT TIMETABLE 
 
• August 2020 
o Submission to NHSGGC Research and Development 
o Redrafting as required 
• January 2021 
o Ethics submission through IRAS to Research Ethics Committee (REC) 
o Book REC meeting 
• February 2021 
o Redrafting as required 
o Approval granted 
o Resubmit to NHSGGC R&D for final approval 
• March 2021 
o Begin data collection  
• June 2021 
o End data collection 
o Analysis 
• July 2021  
o Submission 
• August 2021 

 
 
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o Draft paper submission 
• September 2021 
o Viva 
• Oct 2021 
o Corrections, paper submission 
 
 

 
 
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