We're open and still helping people every day. Our 700 accredited CBT therapists are ready and here to support you too.Please come forward, and help us to help you.

Biomarkers Research Study Privacy Notices

  • What data will be collected by this app and how will it be used?

    If you have decided to take part in this study, you will be using this app and your Fitbit alongside a course of CBT therapy with Ieso Digital Health and will have signed a consent form and contract with us. In this part of the study, this app will ask your permission to collect data from your phone and your Fitbit.

    Data collected 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.

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

    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. This allows the app to show you associations between your behaviours (e.g. physical activity, sleep, location and social interaction) and your mood.

    If you are in the “patient and therapist” arm of the study, your therapist will also be able to view the associations between your behaviours and your mood. They will use this information to inform your course of therapy. You will be able to discuss the data with your therapist.

    The legal basis for processing your personal data under the GDPR is Article 6 (1) (b) contract, and for the sensitive health data it is Article 9 (2) (j), scientific research.

  • How will my data be used?

    Ieso Digital Health 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 Cognitive Behavioural Therapy (CBT).

    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. Your data will be used to 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.

    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. This study has also been reviewed by an NHS Research Ethics Committee and been given a favourable opinion.

  • How will my data be processed and stored?

    Data collected by this app will be processed locally within your 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 stored confidentially and securely in the UK, within a Microsoft Azure cloud environment managed by Ieso. Biotaware Ltd will have access to data associated with your Fitbit activity, but no access to personal identifiable data from your Fitbit profile, such as name, 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 this app, including Fitbit data, contains no directly identifiable information and is identified by a unique identification number. These data will be securely transferred to a Microsoft Azure cloud environment managed by Ieso, via an encrypted connection. Together with therapy data, these data will be stored confidentially and securely within an Ieso managed 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).

  • 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.

  • Who will have access to my data?

    If you have decided to take part in this study, and you are in the “patient and therapist” arm of the study, your therapist will be able to view the associations between your behaviours and your mood. They will use this information to inform your course of therapy. You will be able to discuss the data with your therapist.

    Ieso researchers will also access study-specific data and documents. This data will be identified by a unique study-specific number and/or code, not by name. Your name and any other directly identifying details will not be included in any study data electronic files accessed by Ieso researchers.

    To facilitate patient invitation and enrolment in the study, a specially trained member of the research team will have been given temporary access to your case file, which includes directly identifiable information such as your name and email address. Once a therapist has been allocated to you, the researcher will only access your case file if technical support is requested by the you or your therapist. The researcher will never access therapy transcripts or messages between you and your therapist. This member of the research team has received specialist training on how to handle patient data and adheres to strict privacy policies. Your personal information is strictly confidential and will not be published, shared or discussed with anyone for the purposes of this study.

  • What are my Data Protection Rights?

    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 (Ieso only publish aggregated data; your name or personal identifiable data will never be included in any publication), 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.

    If you feel there is an error of fact in your personal data held by us and we agree the information is incorrect, the alteration will be made. If we are not satisfied the information is factually incorrect, a note will be made of the information you consider is inaccurate, and you will be notified of either the correction or the note.

    Data protection law also includes the right to data portability and to make other requests to seek to erase, object to and restrict personal data processing where certain limited grounds apply. Note however that data processed for health/treatment and legal purposes, or where other legitimate grounds for the processing apply, are examples of circumstances where some of these rights can be restricted or not apply in practice.

    If you are unhappy with a response you receive regarding your data protection rights, you can refer the matter to the Information Commissioner's Office.

  • Contact details

    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.

In an emergency
Call 111 - if you urgently need medical help or advice but it is not a life threatening situation
Call 999 - if you or anyone else is in immediate danger or harm
Call the Samaritans 24 hours a day on 116 123