Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence: a Mixed Methods Pilot Study
Phase: NA
Conditions: Insomnia, Breast Cancer, Adherence, Medication, Quality of Life, Survivorship
Sponsor: University of Strathclyde

Protocol: The influence of cognitive behavioural 
therapy for insomnia on self-reported endocrine therapy 
adherence: a mixed methods pilot study 
 
University of Strathclyde: UEC23/09 
Document date: 20/02/2023 
 
 
 
 

1. Introduction 
Breast cancer (BC) is the most common type of cancer in the UK, and the highest cause of 
cancer-related death in women(1). Approximately 70% of BC cases are hormone-receptor 
positive, which means the cancer cells grow in response to hormones oestrogen and/or 
progesterone. Following primary treatment (usually surgery, chemotherapy and/or 
radiotherapy), these cases are treatable with endocrine therapy. This is prescribed in the form 
of daily tablets for 5-10 years. This treatment works by either reducing the volume of 
oestrogen produced in the body (Aromatase inhibitors) or preventing oestrogen from binding 
to its receptors (Tamoxifen) (2).  
When it is taken as prescribed, endocrine therapy is successful in reducing the risk of breast 
cancer recurrence and mortality. Tamoxifen can reduce the risk of recurrence by up to 50%, 
and aromatase inhibitors can reduce the chance of recurrence by a further third in 
comparison(3). Despite the clinical advantages of ET, compliance with this medication is 
often not optimal. Research indicates that up to half of those prescribed ET take their 
medication less than 70% of the time(4). This reflects suboptimal adherence (the extent to 
which patients take the medication as prescribed) and persistence (the duration of medication 
use, from initiation to discontinuation) (Wasserman et al., 2017). Nonadherence and 
nonpersistence are related to increased risk of BC recurrence and mortality(5). Therefore, to 
further improve BC outcomes, adherence to this medication should be maximised. 
Predictors of ET adherence include younger and older age, switching ET medication type, 
comorbidities, and out of pocket medication costs(6). Another major factor which makes 
adherence challenging is side effects, which have severe impacts on quality of life and sense 
of identity and returning to normality after cancer treatment(7,8). These recent studies 
indicate that side effects may present a means of improving adherence as BC survivors 
express a desire for support in managing them, and they are amenable to improvement than 
demographic and clinical predictors.  
One side effect which may present an appropriate target is insomnia. Characterised by 
difficulty falling and staying asleep, insomnia common in cancer patients and especially 
among those diagnosed with BC(9). This is debilitating to carrying out daily activities and 
has further effects on mental health and ability to move on from BC treatment(8). 
Importantly, sleep problems are influenced by other treatment side effects such as hot flashes, 
night sweats, and musculoskeletal pain, and related to depression and anxiety in BC 
survivors(10,11). Insomnia is therefore a transdiagnostic symptom with the potential to 

reduce the burden of several different ET side effects and overall quality of life. Unlike hot 
flashes and pain, sleep can be treated non-pharmacologically using cognitive behavioural 
therapy, which is considered the gold standard treatment for insomnia (12). This has been 
found to improve not only insomnia symptoms but also depression, anxiety, and fatigue in 
BC survivors(13), and can be delivered efficiently to groups of people and treat these 
symptoms non-pharmacologically(14,15).  
Thus far, interventions to improve ET adherence have focused on patient education and 
reminders to take medication, which have had little success in improving adherence (Ekinci 
et al., 2018; Heiney et al., 2019). Recent protocols include components of side effect 
management(16), which addresses research finding that BC survivors express a desire for 
support and willingness to try new strategies with the aim of better side effect management 
(7,8). However, to the best of our knowledge, there have been no attempts to improve 
adherence by targeting a specific ET side effect. Sleep may present an opportunity here as it 
is a transdiagnostic target which is highly prevalent in this population, and can be effectively 
treated non-pharmacologically using CBT-I. 
This study will utilise a randomised, waitlist-controlled design. We will aim to recruit 40 BC 
survivors who experience sleep problems and struggle to take their ET medication as 
prescribed. The main objective of this study is to explore the effect of CBT-I (delivered 
through videoconferencing) on sleep problems and adherence to ET in BC survivors.  
 
2. Methods  
2.1. Design 
The study is a randomised, waitlist-controlled trial of CBT-I. The advantages of a waitlist 
control group are: this ensures all participants have the opportunity to receive the 
recommended treatment for insomnia, and that by utilising control participants as 
intervention participants after their participation in the control condition, we can increase the 
statistical power of the study. The immediate intervention group will complete assessments at 
baseline, post-intervention (approximately 4 weeks after baseline), and after a further 8 weeks 
(12 weeks post-randomisation follow-up). The waitlist group will complete these assessments 
at the same timepoints, then 2 additional assessments after they receive the intervention, and 
after a further 8 weeks. The study is expected to take approximately 12 weeks from baseline 

to completion (follow-up assessment). This study has been granted ethical approval has been 
granted from the University of Strathclyde ethics committee (UEC23/09).  
2.2. Participants 
Participants will include BC survivors who: experience symptoms of insomnia, self-report to 
be nonadherent to their ET medication, are fluent in English, and have access to 
videoconferencing software. Treatment nonadherence and insomnia symptoms will be 
established first during the screening interview, and at baseline, by responses to the 
Medication Adherence Report Scale (MARS-5) and Sleep Condition Indicator (SCI), 
respectively, using established cut-off scores.  
Exclusion criteria include: individuals who are currently pregnant or breastfeeding, have 
received CBT-I within the past 12 months, have received chemotherapy or radiotherapy 
within the past 4 weeks or have plans for future treatment, struggle with substance misuse, or 
have an unstable physical or mental health condition (e.g. psychosis) which would be 
incompatible with CBT-I treatment.  
Participants will not be excluded on the basis of other sleep disorders, if they report that these 
are stable and well-managed. Participants will not be excluded on the basis of a palliative BC 
treatment plan. However, during the screening interview the nature of CBT-I treatment will 
be explained to them, as this treatment can be difficult to implement, and they will be asked if 
they feel well enough to participate.  
2.2.1. Recruitment 
We will aim to recruit a sample of 40 participants.  A-priori power analysis was conducted 
using G*Power version 3.1.9.7 (Faul et al., 2007) to determine the minimum sample size 
required to test the study hypothesis using a repeated measures ANOVA (within-between 
interaction). Results indicated the required sample size to achieve 80% power for detecting a 
medium effect (significance criterion α=.05) was N=18. Therefore, the target sample size of 
N=40 is adequate to test the study hypothesis. 
Recruitment will involve emailing participants of a previous study (UEC21/29) who 
indicated that they would be interested in participation in future research studies. We will 
contact individuals from this sample whose responses indicated they are nonadherent to their 
ET medication and experience significant sleep problems, informing them of the opportunity 
to take part in this study. 

The initial email will briefly outline the nature of the study and include an information sheet 
with full study details. Those who are interested will be asked to respond to this initial email 
so that a screening interview can be scheduled.  
2.3. Procedure 
Those who indicate interest in participation will be emailed a link to a virtual consent form 
via Qualtrics survey platform. Following informed consent, a screening interview will be 
scheduled. They will then be interviewed to ensure eligibility criteria are met. Screening 
interviews will be carried out by the PhD student: if there are any points of uncertainty, 
clarification will be sought through discussion with academic supervisors. Those who meet 
inclusion criteria following screening will be sent a link to the baseline assessment, then 
randomised to either the intervention or waitlist control group. All further assessments will be 
sent via email and carried out through Qualtrics survey platform. 
2.4. Randomisation 
Participants will be allocated on a 2:1 basis to the waitlist or intervention group. The study 
team will have no influence over the randomisation process. Participants will be randomised 
using block randomisation in blocks of 10. The advantage of this method is that it maintains 
balance between intervention and control group, as significant imbalance would reduce the 
power of the study in a small sample (Lim & In, 2019; Pinto et al., 2022). 
Upon providing informed consent, participants will be assigned a unique identifier (UID). A 
PhD student unrelated to the study will be given a list of these UIDs and use an online 
randomisation tool to generate an allocation sequence, which will be used to assign each 
group’s participants. They will then pass the list of UIDs assigned to each group to the PhD 
student for the study, who will establish which participants are in each group. Following 
randomisation, the intervention group will be emailed a recurring link to access CBT-I 
sessions via videoconferencing. 
2.5. Intervention 
CBT-I is a multi-component, evidence-based intervention which incorporates both cognitive 
and behavioural techniques to address symptoms of insomnia, aiming to improve satisfaction 
with the duration and quality of sleep by reducing trouble falling and/or staying asleep.  Its 
main components include: sleep restriction, stimulus control, and cognitive restructuring. 
Sleep restriction aims to reduce discrepancy between time spent in bed and time actually 
sleeping by improving ‘sleep efficiency’ (SE), which is the time spent sleeping expressed as a 

percentage of time spent in bed. The individual is given a prescribed bedtime and waketime 
to match their time spent in bed with time sleeping, which is adjusted accordingly when their 
SE reaches 90%, or falls below 85%. Stimulus control involves strengthening the association 
between being in bed and being asleep, by minimising activity in the bed unrelated to sleep or 
intimacy, getting out of bed if unable to initiate sleep or get back to sleep after waking up, 
and only returning to bed when sleepy. Cognitive restructuring challenges maladaptive 
beliefs about sleep and concerns about the daytime consequences of poor sleep, to reduce 
arousal and anxiety associated with insomnia.  
CBT-I will be delivered over 4 weekly 1-hour sessions, via videoconferencing. Session 1 will 
include psychoeducation about sleep (the relationship between sleep and mental health, the 
‘3P’ model of insomnia), and begin to explain components of CBT-I (sleep restriction and 
relaxation). Session 2 will reinforce previous learning about these components and introduce 
stimulus control. Session 3 will introduce sleep hygiene and its importance in preventing poor 
sleep. Session will 4 discuss cognitive therapy techniques and relapse prevention.  
Participants in the waitlist condition will receive the CBT-I intervention after completing the 
12-week follow-up assessment. This will then be used as a baseline measure for these 
participants to compare to their post-intervention and follow-up after receiving the treatment. 
The intervention will be delivered by a PhD student, who will receive extensive CBT-I 
training from supervisors who have over 15 years’ experience in delivering CBT-I. The 
student will receive continuous supervision throughout. Sessions will be recorded and 10% 
will be assessed by supervisors to monitor treatment fidelity. 
2.6 Measures 
2.6.1. Primary outcome 
Medication Adherence Report Scale (5 item) (MARS-5). The MARS-5 will be used to measure 
self-reported nonadherence to ET medication. This includes 5 items which measure 
nonadherence behaviours, scored from 1 ‘Always’ to 5 ‘Never’. Item 1 measures unintentional 
nonadherence (i.e., forgetting to take medication), whereas 2-5 represent intentionally not 
taking medication as prescribed (e.g., altering the dose of medication), with higher scores 
meaning better adherence. In past research, a total score ≤ 4 (on the unintentional nonadherence 
subscale) and ≤ 19 (on the intentional nonadherence subscale) have been used to classify 
participants as nonadherent. Scores are summed to create a total ranging from 1-5.  
2.6.2. Secondary outcomes 

The Sleep Condition Indicator (SCI) measures insomnia symptoms with 8 items, scored from 
0-4. Responses are summed to create a total score ranging from 0-32, with higher scores 
meaning better sleep. A total score of ≤ 16 indicates probable insomnia disorder.  
The Patient Health Questionnaire (PHQ-9) measures depressive symptoms using 9 items which 
each measure a different symptom. This measure is scored from 0-3, with higher scores 
indicating more severe symptoms. A score of ≥ 10 is recommended as a threshold for moderate 
to severe depression.  
The Generalised Anxiety Disorder Assessment (GAD-7) measures symptoms of General 
Anxiety using 7 items scored from 0-3. Responses are summed to create a total score: a score 
of ≥ 10 indicates moderate-severe anxiety.  
The Flinders Fatigue Scale (FFS) measures how often participants have felt bothered by 
fatigue, with 7 items where higher scores indicate worse fatigue. Six items are scored from 0-
4, whereas item 5 includes a checklist which is scored from 0-7. Responses are summed to 
create a total score of 0-31. A score of ≥ 16 indicates moderate to severe (≥ 21=severe) fatigue. 
The Breast Cancer Eight Symptom Scale (BESS) includes 3 subscales: this study will use the 
vasomotor symptoms and musculoskeletal pain subscales. These subscales include 3 items, 
scored from 1-3. Scores are summed, multiplied by the number of items in the subscale, and 
then divided by the number of questions answered, with higher scores indicating worse 
symptoms. 
The consensus sleep diary will be to collect self-reported data about variations in sleep for 
each participant. These will be completed daily (to reflect the previous night’s sleep) for one 
week at a time. Sleep diary data will include SE, sleep onset latency (SOL), wake after sleep 
onset (WASO), total sleep time (TIB), time in bed (TIB), and number of night-time 
awakenings. All participants (intervention and control group) will complete a baseline sleep 
diary for one week prior to the intervention period, then complete sleep diaries throughout the 
4-week intervention period.  
2.7 Analytic approach 
Participants demographics and clinical characteristics will first be presented. Descriptive data 
will be presented for each outcome measure (MARS-5, SCI, GAD-7, PHQ-9, FFS and BESS 
subscales) and sleep diary variables at each of the 3 timepoints (baseline, post-intervention, 
and 12-week follow-up).  

Hypotheses will be tested using a 2x3 mixed factorial ANOVA. Between-subjects factor will 
be group (intervention or control), and within-subjects factor will be timepoint (baseline, 
post-intervention, and 12-week follow-up). We will examine the main effect of group, 
timepoint and interaction of group and timepoint. If a significant main effect is found, 
subsequent comparisons will be made applying Bonferroni correction. 
 
3.  Discussion 
3.1. Study strengths and limitations 
When taken as prescribed, ET is successful in reducing the risk of BC recurrence (EBCTCG, 
2011). However, suboptimal adherence and persistence are an issue with this medication. To 
date, efforts to improve ET adherence have had little success, mostly focusing on patient 
education or reminders to reduce the risk of forgetting medication (Heiney, Ekinci). Side 
effects have been identified as a consistent predictor of ET nonadherence (Moon et al., 2019; 
Cahir et al., 2015; Pan et al., 2018), and are more amenable to change than demographic or 
clinical predictors. However, a recent systematic review (Fleming et al., 2022) reported a lack 
of consensus on the influence of specific side effects on ET nonadherence, which inhibits the 
identification of appropriate, targeted intervention strategies. This pilot study will explore the 
influence of a targeted intervention for sleep problems (CBT-I) on self-reported ET 
adherence in a sample of BC survivors.  
Previous efforts to improve ET adherence have focused mostly on reminders or patient 
education, with little success (Ekinci et al., 2018; Heiney et al., 2019). However, recent 
studies report that participants express a desire for support with self-management of side 
effects (Arch et al., 2022; Hall et al., 2022; Jacobs et al., 2022). Jacobs et al. (2021) reported 
that participants found sessions focused on self-management of ET side effects such as sleep 
difficulties, hot flashes, and pain most useful. However, to the best of our knowledge, no 
studies have attempted to enhance adherence by targeting specific side effects. The current 
study will therefore directly address a perceived lack of support with side effects expressed 
by BC survivors (Peddie et al., 2021), and address a gap in the literature by investigating a 
specific, targeted intervention which may improve ET adherence. 
Sleep problems are one of the most common ET side effects (Colleoni et al., 2018; Boldyrev 
et al., 2021), and have been associated with fatigue, musculoskeletal pain, and vasomotor 
symptoms (Desai et al., 2017; Leysen et al., 2019). Therefore, insomnia is a prevalent, 

transdiagnostic side effect which may present an appropriate target for intervention to relieve 
overall side effect burden and improve ET adherence. CBT-I is considered the gold standard 
gold-standard treatment for insomnia (Ma et al., 2021), and has been effective in this 
population before in reducing not only sleep, but also depression, anxiety, and fatigue 
(D’arico et al., 2016).  
The current study will administer CBT-I in groups of approximately 5 participants, through 
videoconferencing. A recent meta-analysis found no significant difference between remotely-
delivered and conventional face-to-face CBT-I and reported that remotely-delivered CBT-I 
may be slightly more efficacious in comparison to in-person treatment (Ma et al., 2021). This 
format also has the advantage of widening accessibility, removing the financial and practical 
burden of travelling to in-person sessions. Delivering the intervention using a group (rather 
than individual) format presents a time-efficient and cost-effective intervention (Garland et 
al., 2022), and also addresses preferences expressed by BC patients to receive support with 
side effects in a group setting, so that they can learn from their peers’ experiences (Jacobs et 
al., 2020). Despite being the gold-standard treatment for insomnia, clinician and patient-level 
barriers have limited access to this intervention (Koffel et al., 2018; Savard et al., 2021). The 
mode of delivery utilised in the current study therefore widens accessibility of the 
intervention. Furthermore, A recent systematic review by Peddie et al. (2021) reported that 
BC survivors showed high motivation to continue treatment, and willingness to make 
lifestyle changes to reduce the burden of side effects and persevere with ET. This willingness 
to try different strategies to reduce side effect burden indicates that they may be receptive to 
behavioural intervention such as CBT-I.  
In addition to the mode of delivery of intervention, the design of the current study presents 
another strength. This study uses a repeated measures waitlist control, which is ethical as we 
will not be denying treatment to any participants. However, this could also be representative 
of real-world health services where patients frequently face extended waiting times (Garland 
et al., 2021; Koffel et al., 2018). A waitlist control design has been questioned due to the 
possibility of ‘waiting effect’ where participants may wait to change their behaviours until 
they receive an intervention, therefore delaying improvements, which is a potential ethical 
concern (Garland et al., 2021). However, insomnia tends to exist as a chronic, persistent issue 
in cancer patients, meaning participants are unlikely to improve without appropriate treatment 
(Savard et al., 2011).  
3.2. Conclusions 

The outcomes of this study will improve our understanding of potential targeted intervention 
strategies to reduce ET nonadherence, addressing a significant gap in the existing ET 
adherence literature (Fleming et al., 2022). By exploring the influence of improved sleep on 
self-reported nonadherence, we will investigate if sleep may be an effective target for 
intervention, and the potential for improving sleep to reduce overall side effect burden in BC 
survivors. If successful, these results will support the use of remote CBT-I to efficiently treat 
insomnia (a prevalent, burdensome issue among BC survivors), improve ET adherence, and 
potentially improve long-term BC outcomes in future.  
 
 
 
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statistics for the year 2020: An overview. Int J Cancer 2021 -04-22;149(4):778. 
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Oncology. 2022 Mar 1;23(3):382-92. 
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Experience of Adjuvant Hormone Therapy: A Thematic Analysis of Medication Side Effects 
and Their Impact on Adherence. Frontiers in psychology 2022;13:861198. 

(8) Peddie N, Agnew S, Crawford M, Dixon D, MacPherson I, Fleming L. The impact of 
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Informed consent form 
University of Strathclyde: UEC23/09 

Document date: 02/05/2023 
 
 

 
School of Psychological Sciences and Health 
University of Strathclyde 
Graham Hills Building 
40 George Street 
Glasgow, G1 1QE 
Tel: 0141 548 2669 
Information Sheet 
We would like to invite you to take part in a research study. Before you decide you need to 
understand why the research is being done and what it would involve for you. Please take time to 
read the following information carefully. Talk to others about the study if you wish. Feel free to 
contact us if you have any concerns, or you would like more information. 
 
Who is conducting the research? 
The research is being carried out as part of a PhD project within the Sleep Research Unit of 
Strathclyde University, supervised by Dr Leanne Fleming, Dr Megan Crawford, and Dr Iain 
MacPherson. 
 
What is the purpose of the study? 
The broad aim of this study is to test whether a cognitive behavioural treatment for insomnia helps 
improve adherence to hormone therapy medication in breast cancer survivors. 
 
Why have I been invited? 
We are contacting you as you previously took part in an online survey which was the first part of this 
PhD research project, and indicated you may be interested in future studies by leaving your email 
address. If you no longer wish to participate in research studies on this topic, please feel free to 
disregard this information sheet and accept our thanks for your previous participation. You have been 
invited to take part as you reported that you are prescribed hormone therapy medication and have 
also reported problems with your sleep.  
Who can take part in the study? 
People meeting the following criteria may be eligible to take part: aged 18 or over, prescribed 
hormone therapy treatment for breast cancer, problems with sleep, find it difficult to take hormone 

therapy medication as prescribed, speak English, and have access to videoconferencing 
equipment/software.  
Due to the nature of the study, people would be ineligible to participate if they: are currently pregnant 
or breastfeeding, undertake shift work (i.e., nightshift), have received chemotherapy or radiotherapy 
within the past 4 weeks (or will be receiving these treatments in the future), have trouble with 
substance misuse (such as alcohol or drugs), or an unstable mental health condition which could 
interfere with the study or make participation unsafe.  
 
Do I have to take part? 
No, you do not have to take part. You will be asked to sign a consent form to show you have agreed 
to take part. You are free to withdraw at any time, without giving a reason.  
 
What does taking part involve? 
Once you have agreed to participate in the study, we will ask you to sign a consent form. There are 5 
stages of this research study.  
 
Stage 1: Screening First, we will conduct a screening evaluation via a video call using Zoom. During 
this screening, we will ask you some questions about your current physical and mental health, and 
your sleep. These questions may be of a sensitive nature, and you do not have to answer questions if 
you do not want to. That screening will take about 45-60 minutes.  
 
Stage 2 Baseline assessment: We will ask you to complete a baseline assessment through an online 
questionnaire. This will ask some questions about your mental and physical health, your sleep, and 
how you take your hormone therapy medication. This will take about 15-20 minutes. We will also 
ask you to complete a daily sleep diary for one week. It will take you around 5 minutes to complete a 
diary entry each morning. Completing the diary before you start the study is routine procedure and 
provides us with a final check that you meet all of our study criteria. If we determine that you do not 
meet criteria for our study, we will have to exclude you from the study. If that is the case, we will 
provide you with some general information about how to improve your sleep. 
 
Stage 3: Randomisation: If you eligible to take part in the study, you will be randomly allocated to 
one of two groups. This will not affect the treatment you receive, it will only affect whether you are 
in the group which receives the treatment first or second. Both groups will complete a series of 
questionnaires, and keep a diary of their sleep to record any changes over time. If you are assigned 

to the second group, you will receive the treatment after 12 weeks. Depending on the group 
participants are randomised to, participation will last either 12 weeks or 24 weeks and participants 
will not know until they have consented how long participation will last for. Random allocation 
means neither you, nor the research team has control over which group you are assigned to. 
 
Stage 4: Treatment and follow-up assessments:   
The study will involve 4 sessions of cognitive behavioural therapy for insomnia, keeping a diary with 
some details about your sleep, and completing a series of questionnaires at different timepoints. 
Sessions will be delivered weekly for 4 weeks. These will last 45-60 minutes. The sessions will be 
delivered in groups, meaning there will be around 5 people in each session receiving the treatment. 
This will be delivered through video calls on Zoom. A member of the research team will email you an 
invitation to these meetings and contact you to confirm you are able to join.  
During the 4-week intervention period, both the group receiving the intervention and the waitlist 
group will keep a diary of their sleep so that we can observe any changes over time. We will ask you 
to complete the same questionnaires as in the baseline assessment, 4 weeks after the baseline 
questionnaire, and 8 weeks after this. If you are assigned to the second group (meaning you receive 
the intervention after 12 weeks), you will be asked to keep a sleep diary again during the treatment, 
complete the questionnaires again after receiving the treatment, and again 8 weeks after this. The 
purpose of this to assess any changes to your scores over time. 
 
Stage 5: Participant feedback 
When you complete the questionnaires 8 weeks after finishing the treatment, you will be invited to 
take part in an exit interview to discuss your experience and things you found especially 
helpful/unhelpful about the intervention. You can opt out of this if you choose to. There will also be 
some open-ended questions in the post-treatment assessment where you can leave written 
feedback if you would like to. 
 
What happens to the information? 
The data are held in accordance with the Data Protection Act, which means that we keep it 
safely. If you decide to be in this study, the study researchers will gather information that identifies 
you, and about your personal health. All information will be kept on the University of Strathclyde’s 
secure server (Strathcloud), in password-protected files, and only the study team has access to that 
folder. 
The raw data from this study will be made available as “open data” through a research data 

repository. This will not include any identifiable information (e.g., your name, date of birth, or email 
address). This means the de-identified study data will be publicly available and may be used for 
purposes not related to this study. 
Identifiable information (e.g., name, date of birth, address): Information that might directly identify 
you, such as your name and address will be collected. This information will never be kept in the same 
place as the information about your health. Identifiable information will be kept for the length of the 
study and a fixed period afterwards (no more than 3 months). This is so we can contact you if we 
have any questions about your participation in the study. After that time, it will be confidentially 
destroyed.  
Keeping the identifying and health information separate: All of your health information (e.g., about 
your sleep and mental health) will not be linked to your identifying information (e.g., your name). 
We will ensure this by assigning you a unique study ID. This is a process called de-identifying the data 
and means that personal information that could reasonably identify you will be removed or changed 
before data is shared with other researchers or the results are made public. A file that identifies you 
to your study ID, will be kept secure, separate from the rest of your data, and available only to the 
research team. Any information that can identify you will remain confidential. 
Sensitive information: In cases, where you disclose information about suicidal ideation or 
physical/sexual abuse to you or others, the chief investigator will be obliged to contact the respective 
authorities (e.g., local mental health crisis team), even if you do not give consent for us to do so.  
What if I withdraw: You can withdraw from the study at any time. If you choose to withdraw, we will 
ask your reason(s) why, so that we can better understand the experience of the participants. 
However, you do not have to give a reason if you do not want to. If you withdraw during the study, 
the data collected from you can be removed from the study records. If you wish to withdraw your 
data after completing the study, it can be removed from study records within 4 weeks after you have 
finished. At this point, the data from all participants will be assessed together, therefore individual 
data cannot be removed. However, no personal/identifiable data will be included the final report.  
 
What are the possible benefits of taking part? 
By taking part in this research, you will be providing valuable information regarding the treatment of 
insomnia in people who are prescribed hormone therapy. This will help us to investigate if is feasible 
to deliver this treatment on a larger scale study to people prescribed hormone therapy. While we 
cannot guarantee that you will experience improvements, we hope that you will see some changes in 
your sleep and your mental health.  

 
What are the possible risks of taking part in the study? 
We do not anticipate any serious risks associated with participation in this study. Some of the minor 
risks that we anticipate are:  
• 
As you make changes to your sleep behaviours, you might experience side effects such as: 
fatigue, extreme sleepiness, reduced motivation/energy, irritability, and changes to 
hunger/appetite. These have been found to subside as treatment goes on. However, if 
any of these symptoms worsen, we advise you abstain from driving or operating heavy 
machinery and contact your health care provider if you become concerned. 
• 
The questions asked during the screening evaluation might be personal and sensitive (for 
example about your current mood). You may stop the screening interview at any time. 
 
What if there is a problem? 
If you have any questions or concerns related to the study or the treatment, feel free to contact the 
research team using the contact information at the end of this form. Any changes in your health that 
you are concerned with should be shared with your GP.  
 
Who has reviewed the study? 
This study has been reviewed by the University of Strathclyde ethics committee. 
 
 
Researcher contact details:   
 
Sommer Agnew, University of Strathclyde 
sommer.agnew.2019@uni.strath.ac.uk 
 
  
Chief Investigator details:  
 
Dr Leanne Fleming,  
University of Strathclyde,  
0141 548 4705 
l.fleming@strath.ac.uk 
 
 
 
If you have any questions/concerns, during or after the research, or wish to contact an independent 
person to whom any questions may be directed or further information may be sought from, please 
contact: 
  

Secretary to the University Ethics Committee 
Research & Knowledge Exchange Services 
University of Strathclyde 
Graham Hills Building 
50 George Street 
Glasgow 
G1 1QE 
 
Email: ethics@strath.ac.uk 
 
 
Contact details for support organisations: 
  
If you are worried about your own responses to the questions of this study, or if you are feeling 
distressed, we recommend that you contact your GP or one of the support organisations listed 
below.  
  
·       Breast Cancer Now 
Free confidential phone and web-based service providing support and information from breast 
cancer nurses for people who have been diagnosed with breast cancer throughout the United 
Kingdom.  
Weekdays: Monday to Friday — 9am to 4pm 
Weekend: Saturdays — 9am to 1pm 
Contact: 0808 800 6000 
https://breastcancernow.org 
  
·       Local GP 
Visit your local GP to discuss any issues you may be concerned about and for information of available 
local support services. 
www.nhs.uk/service-search 
  
·       NHS 24 
If you need urgent health advice when your GP Practice is closed.  
Contact: 111 
http://www.nhs24.scot/ 
  
·       Samaritans 
Free confidential phone and web-based service providing emotional support to anyone in emotional 
distress, struggling to cope, or at risk of suicide throughout the United Kingdom and Ireland. 
This is a 24-hour service. 
Contact: 116 123 
www.samaritans.org 
  
·       Breathing Space 
Free confidential phone and web-based service for people experiencing low mood, depression or 
anxiety.  
Weekdays: Monday – Thursday 6pm – 2am 
Weekend: Friday 6pm – Monday 6am 
Contact: 0800 83 85 87 
www.breathingspace.scot 
  

  
·       NHS Website 
Free self-help tips on dealing with insomnia: 
https://www.nhs.uk/conditions/insomnia/ 
  
Free self-help tips on dealing with fatigue: 
https://www.nhs.uk/live-well/sleep-and-tiredness/self-help-tips-to-fight-fatigue/ 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Consent Form  
   
Name of department: School of Psychological Sciences and Health  
Title of the study:   
   
-  I confirm that I have read and understood the Participant Information Sheet for the above 
project and the researcher has answered any queries to my satisfaction.  
   
- I confirm that I have read and understood the Privacy Notice for Participants in Research 
Projects and understand how my personal information will be used and what will happen to 
it (i.e. how it will be stored and for how long).  
   
- I understand that my participation is voluntary and that I am free to withdraw from the 
project at any time, up to the point of completion, without having to give a reason and 
without any consequences.    
   
- I understand that anonymised data (i.e. data that do not identify me personally) cannot be 
withdrawn once it has been analysed.   
   
- I understand that any information recorded in the research will remain confidential and no 

information that identifies me will be made publicly available.  
   
- I consent to being a participant in the project.  
  
  
  
o Yes 
 
  
o No