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You are invited to take part in a research study

TITLE OF THE STUDY: COGNITIVE AND BEHAVIOURAL BIOMARKERS IN MENTAL HEALTH THERAPY

Ieso Digital Health is a provider of online cognitive behavioural therapy (CBT). Ieso provides this service to NHS patients, free of charge, in many areas of the UK. Ieso are running a study to evaluate how information on patients’ language, physical activity and behaviours can be used to improve the effectiveness of psychological therapies, such as CBT.

You are free to decide whether or not to take part in this study. Before you make your decision, it is important for you to understand why the research is being done, and what it will involve. You may want to talk to others about the study before taking part. If you decide to participate you may change your mind at any time.

If you have any questions about this study you can contact a member of the research team at biomarkers.research@iesohealth.com, or the Chief Investigator of this study Ana Catarino at a.catarino@iesohealth.com or on 0800 074 5560.

Alternatively, you may contact the Ieso Digital Health Clinical Operations Manager, Shazna Khanom at s.khanom@iesohealth.com, or UK Service Lead, Jack Southward at j.southward@iesohealth.com, or by phone on 01223 608760.

This study is funded by Innovate UK through the Industrial Strategy Challenge Fund's Digital Health Technology Catalyst via Research Councils UK, and sponsored by Ieso Digital Health and Biotaware Ltd.

Part 1 tells you about the purpose of the study and what will happen to you if you take part.

Part 2 gives you more detailed information about the conduct of the study.

Part 1

  • Overview of the study

    Common mental health disorders such as anxiety or depression can have a significant impact on a person’s ability to function. Many studies have shown a clear relationship between our mental health and our behaviours, including the way we talk, the places we visit, or how we sleep. When it comes to treatment, there is a strong evidence base that supports the effectiveness of cognitive behavioural therapy (CBT) for patients with these disorders. However, it remains unclear how information about patients’ behaviours can be used in CBT to improve care and make therapy more effective. This study will help us understand if information about a patient’s behaviours can be used by the patient themselves and their therapist to improve treatment, and help the patient feel better, quicker.

  • Why am I being invited to participate in this study?

    You are being invited to participate because you have self-referred or were referred to Ieso Digital Health for cognitive behavioural therapy (CBT). Anyone over the age of 18, who has experienced any symptoms of low mood or anxiety, and owns an internet-connected mobile phone, running Android version 7.0 or higher is invited to participate in this study. You can find out about your phone’s operating system version in the “About phone” section of your phone settings. People who are not suitable for this study will still be offered online CBT, as part of standard care. We are planning to have a total of 200 people take part in this study.

  • What is CBT?

    Cognitive behavioural therapy (CBT) is a talking therapy. It has been proved to help with a wide range of emotional and physical health conditions in adults and young people. CBT looks at how we think about a situation and how this affects the way we act. In turn, our actions can affect the way we think and feel. The therapist and patient work together to change the patient’s behaviours thinking patterns or both of these.

    CBT is traditionally delivered face-to-face but currently there are not enough therapists to provide treatment for all the people who would benefit from it. New methods of delivering effective interventions are required. One method of delivering CBT is online therapist delivered CBT. Around 20,000 NHS patients have already had CBT using this online method and we know that people are just as likely to get better using online CBT as they are using face-to face methods.

  • What will happen if I decide to take part in this study?

    If you are eligible and decide to take part in this study, you will be sent a unique identification number and a link you can use to download the study app on your phone. You will also be sent a Fitbit activity tracker via the post. Once you receive your Fitbit, you will be able to log into the study app, using your unique identification number.

    The app will ask your permission to collect data from your phone and your Fitbit, for the purposes of this study, including physical activity, sleep, location summary, digital and social interaction data. You can find out more about the data being collected in Part 2 of this information sheet. You will be able to revoke these permissions in the app settings. Personal identifiable information such as your exact location, details of social media profile, or phone numbers of your contacts, will NOT be collected for the purposes of this study.

    At the start of the study, you will also be asked to complete two questionnaires via the study app. These will help us understand more about aspects of your personality, beliefs and values which may have an impact on your mental health. You only have to complete these once and it should take about 10 minutes. The study app will also ask you to rate your mood, each day, by answering one question.

    Setting up the study app should take no longer than 15 to 20 minutes. After this you will be able to view your data, including trends between your mood and other collected data, e.g. trend of mood vs sleep time.

    1 - Study Groups

    If you decide to take part in this study, you will be allocated at random to one of two study groups:

    Patient only app – if you are allocated to this group, you will receive a course of online CBT as part of standard care. You will also be able to log your mood and see and explore your data through the study app;

    Patient and therapist app – if you are allocated to this group, you will receive a course of online CBT as part of standard care. You will also be able to log your mood and see and explore your data through the study app. Your therapist will also be able to see your data, collected by the study app, and will use this to inform the course of therapy. You will be able to discuss your data with your therapist.

    2 - What happens at the end of the study?

    At the end of treatment, your involvement in the study will be complete. You will be able to keep your Fitbit activity tracker. If you wish to continue to use the study app to monitor your mood and behavioural data, these data will still be transferred to Ieso Digital Health. If you prefer, you will be able to revoke permissions for data collection and delete the study app from your phone.

  • What are the benefits of taking part in this study?

    People who take part in this study will receive a Fitbit activity tracker, and be given access to a mobile phone app that allows them to track their daily mood against a range of behavioural data, including physical activity, sleep and phone usage. This gives them access to data and information that they may otherwise not be able to access, and which may be beneficial for monitoring their mental health. In addition, the findings from this study will help us learn whether many more people with anxiety or depression could benefit from this data being made visible to them and incorporated in their course of treatment.

  • What are the possible disadvantages and risks of taking part in this study?

    Due to the nature of this study, there is a small risk of a data confidentiality breach. This study requires participants to consent to the collection of mood, activity, sleep, location, digital interaction and social interaction data through their phone. There is a very small risk associated with the collection and storage of this data. Ieso Digital Health will minimize this risk by following nationally and internationally recognised standards for information security (Cyber Essentials Plus and ISO 27001, https://www.iesohealth.com/en-gb/legal/iso-certificates). All data collected through the study app will be identified by a unique study ID, and will not be linked to any directly identifiable data. In addition, study participants will have the option to passcode protect the app on their phones, to secure the data stored on their mobile devices.

    We anticipate taking part in this study will pose no significant risk to your mental health. All study participants will receive a course of online CBT, delivered by a qualified clinician.

Part 2

  • Receiving therapy

    For both study groups, CBT will be delivered by a qualified Psychological Wellbeing Practitioner (PWP) or a high intensity CBT therapist. In addition, the therapists will have received additional training in how to incorporate patient behavioural data in a course of therapy.

    CBT will be delivered individually, online, using synchronous written communication (similar to instant messaging) via the web-based platform developed and provided by the company Ieso Digital Health (see www.iesohealth.com). This means that the participants can be located in a place of their choosing whilst receiving therapy. Participants may also choose the day and time of day that they have their therapy appointments.

    Participant and therapist will log on to the secure virtual therapy room at the agreed time. This can be done via a computer, tablet or smart phone. The session will take place in real time and progress in the same way as a face to face therapy session. The only difference would be that the method of communication will be through live written (typed) text. Participants will receive an evidence-based treatment which will consist of weekly therapy appointments lasting 60 minutes, with the same therapist. Average treatment durations are 7 treatment sessions over a period of two months, although patients who require more sessions (in order to gain benefit) will be provided with more sessions.

    Participants will also be encouraged to participate in between session practice tasks. These are a routine part of CBT as these can provide valuable opportunities of putting work done in session into practice. In the early stages of therapy practice tasks involve reading hand outs and information relevant to what was covered in the sessions. It would also include mood/thought/activity monitoring sheets that participants would be encouraged to complete, to get a better understanding of how problems present in day to day life and to gain insights into what factors maintain these problems. In later stages of therapy, the practice tasks may include specific CBT techniques taught in session, including thought challenging exercises, behavioural activation, confronting avoidance or other techniques specific to the problems discussed in session.

    Participants will be asked to complete several questionnaires (including the PHQ-9, GAD-7 etc. and possibly some anxiety specific scales e.g. for post-traumatic stress disorder, health anxiety if applicable) before each treatment session. It is anticipated that it will take no more than 5 minutes to complete the questionnaires on each occasion. This standard of care is the same for all Ieso patients, whether or not they decide to take part in the study.

  • What data will be collected as part of this study?

    If you decide to take part in the study, we will ask your permission to collect additional data from you through a study app. This data will be collected from your phone and your Fitbit and will include:

    • Fitbit activity data, including active, cardio and peak minutes per day, total sleep and awake time per day;
    • Location summary measures, including total distance travelled, number of locations visited, time spent at home and maximum distance from home, per day;
    • Digital interaction information, including time spent using your phone, per day;
    • Social interaction information, including time spent on social media or messaging apps per day, number and total duration of calls made, received, and missed, per day.

    Personal identifiable information such as your exact location, details of social media profile, or phone numbers of your contacts, will NOT be collected for the purposes of this study.

    At the start of the study you will also be asked to complete two questionnaires:

    • Schwartz Portrait Values Questionnaire (PVQ-21) – this questionnaire consists of 21 questions aimed at measuring human values constructs such as openness to change, self-enhancement and conservation;
    • Big Five Inventory-2 Short Version (BFI-2-S) – this questionnaire consists of 30 questions aimed at measuring core personality traits such as extraversion, conscientiousness and open-mindedness.

    You only have to complete these once and it should take no longer than 10 minutes. You will also be asked to complete a daily mood questionnaire, by answering one question.

  • How will my information be kept confidential?

    Data collected by the study app will be processed locally within the participant’s mobile phone to provide the summary measures described above. Fitbit data including active minutes and summary sleep data will be obtained from Fitbit by the study co-sponsor, Biotaware Ltd, using an online cloud service, and then securely uploaded to Ieso servers. Biotaware Ltd will have access to data associated with the participant’s Fitbit activity, but no access to data from the Fitbit profile, such as names, e-mail address or date of birth. Biotaware Ltd will have no access to any other study data such as questionnaire scores and therapy data.

    All data collected through the study app, including Fitbit data, contains no directly identifiable information and is identified by a unique identification number. These data will be securely transferred to Ieso servers via an encrypted connection. Together with therapy data, these data will be stored confidentially and securely within the Microsoft Azure cloud environment, in the UK. Ieso Digital Health follows nationally and internationally recognised standards for information security (Cyber Essentials Plus and ISO 27001, https://www.iesohealth.com/en-gb/legal/iso-certificates).

    In all study-specific data and documents, other than the signed consent, the patients will be identified by a unique study-specific number and/or code, not by name. Patients’ names and any other directly identifying details will not be included in any study data electronic files. Your personal information is strictly confidential and will not be published, shared or discussed with anyone for the purposes of this study.

  • What will happen to my data at the end of the study?

    All research data including personal data will be held separately from your patient record, and will be stored for a minimum of 20 years in accordance with Medical Research Council guidance. This includes data collected for the purposes of this study – Fitbit data, location summary measures, digital and social interaction data, daily mood ratings, and beliefs and personality questionnaire data.

    Personally identifiable data collected as part of routine practice (during the course of online CBT) shall be retained per our standard clinical practice. This includes your name and personal details, and your therapy record.

  • Informing your GP

    Whilst the treatment is confidential, and we would never normally contact a person’s GP without their express consent, participants should be aware that there might be occasions where we would need to contact the person’s GP. There are two main reasons that may prompt us to do this. One would be if the therapist assesses that the participant would be at risk of harm to themselves or pose a risk to others. The other reason would be if a participant became distressed during the course of treatment and the therapist assessed that there was a need for a referral to a more specialist service. In these rare instances the therapist would at first seek to gain consent from the participant to share information with the GP and the specialist service. Decisions to break confidentiality are rare, however when they do happen we have robust processes to ensure that the decision to share information is in the participants best interest. This decision will not be made by the therapist alone but will be made by the clinical team and overseen by the Senior Clinician.

  • What will happen with the results of this study?

    At the end of the study, results will be analysed and we will produce a report with our findings. These findings may be published in academic and scientific peer-reviewed journals. Your name or personal identifiable data will never be included in any publication.

    If the study results show that collecting behavioural data from patients and sharing these data with patients and/or therapists leads to improvements in patients’ response to therapy, we may explore the opportunity to roll out this service to a larger number of patients.

  • What will happen if I don't want to carry on with the study?

    You can change your mind about participating in this study at any time. If you change your mind this will not affect your treatment and you will still receive the same standard of care and therapy as offered to all Ieso patients. If you no longer wish to participate in this study you should phone Ana Catarino (Chief Investigator of this study) on 0800 074 5560 or email at a.catarino@iesohealth.com. Alternatively, you may contact the Ieso Digital Health Clinical Operations Manager, Shazna Khanom at s.khanom@iesohealth.com, or UK Service Lead, Jack Southward at j.southward@iesohealth.com, or by phone on 01223 608760.

    If you change your mind your data will be removed from the analysis in this study. Data collected for the purposes of this study will be deleted, unless its deletion seriously impairs the research or renders it impossible. For example, if the findings of this research are already published, it may not be possible to delete the data or remove it from the analyses. Data collected for the purposes of the study includes Fitbit data, location summary measures, digital and social interaction data, daily mood ratings, and beliefs and personality questionnaire data.

    However, your therapy record will be retained as a resource that you can return to at any time you wish. This can help you remember coping strategies, techniques or processes that you learnt in therapy. We retain your clinical record by reference to the IGA Records Management Code of Practice for Health and Social Care guidance for managing health records https://digital.nhs.uk/information-governance-alliance and to support our legal obligations to be accountable for your care. The Code is based on current legal requirements and professional best practice. Our data retention practices are reviewed at least annually in conjunction with industry standards and best practice.

  • Who has reviewed this study?

    All research studies are reviewed by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, well-being and dignity. This study has been reviewed and has been given a favourable opinion.

  • How have patients and the public been involved in this study?

    This study was reviewed by an independent Patient Advisory Group, consisting of patients with former or current mental health disorders and who have received cognitive behavioural therapy. The Patient Advisory Group provided advice on the data being collected as part of the study and how these data should be presented to study participants and therapists. Members of the Patient Advisory Group were also given the opportunity to use the study app themselves and provided feedback which informed app development.

  • What if something goes wrong?

    If you have any complaints about this study you can contact the Chief Investigator Ana Catarino at a.catarino@iesohealth.com or by phone on 0800 074 5560.

    If you wish to make a formal complaint, please submit to:

    Email address: info@iesohealth.com

    Postal address: Ieso Digital Health, Jeffreys Building, St Johns Innovation Park, Cowley Road, Cambridge CB4 0DS

    If you are unhappy with the outcome of your complaint, you can contact the Independent Sector Complaints Adjudication Service (ISCAS): 70 Fleet Street London EC4Y 1EU

    Tel: 020 7536 6091 Email: info@iscas.org.uk

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