You are invited to take part in a research study

The current study aims to explore the use of computer/mobile-based digital therapy tools to enhance the effectiveness of CBT for the treatment of depression and anxiety disorders. Computerised approaches are already a recommended treatment option for those with depression and anxiety, but evidence suggests that acceptance of these so far has been poor. It is hoped that, ultimately, the tools we develop can not only be also more effective in reducing a person’s symptoms, but also be further developed to the stage where digital therapy can be largely autonomous, with minimal or no oversight from a therapist. This would increase access therapies like CBT, both in developed countries, but particularly in areas of the world which have little or no access currently.

Anyone referred to Ieso Digital Health for the treatment of mild to moderate depression or anxiety is eligible to take part in the study. If you chose to take part, you will be allocated at random to one of two groups. One group will receive digitally-enhanced therapy, and the other group will receive standard online therapy.

If you decide to take part in this study, you will need to provide us with your written consent to take part. A consent form will be provided to you for you to sign electronically.

At the outset of the study, you will be allocated at random to one of two groups. One group will receive digitally-enhanced therapy, and the other group will receive standard online therapy.

• Digitally enhanced group: If allocated to this group, you will receive a course of online CBT enhanced by up to six digital tools. These tools, which have been newly developed at Ieso, are for use during the period in between therapy sessions. Your therapist will explain which tools to use but you are free to use as many as you like.

• Standard group: If allocated to this group, you will receive a standard course of online CBT but you will be given standard non-interactive therapy tools, delivered through from the platform as pdf documents.

Those receiving treatment (regardless of which group they are assigned to) may experience improvement of symptoms of depression and anxiety, whilst also gaining easy access to transcripts of therapy sessions and useful tools to help manage their own condition going forward. This will help us learn whether many more people with depression and anxiety could benefit from this way of delivering CBT. Further to this, if our results show that our digital tools can be as effective in providing support for CBT, this will provide a starting point for the continued development of autonomous digital therapy tools.

By taking part in this research, you will potentially be contributing to the development of tools that can not only be more effective in reducing a person’s symptoms, but may also be further developed to the stage where digital therapy can be mostly autonomous, with minimal oversight from a therapist. This would increase access to therapies like CBT, both in developed countries, but particularly in areas of the world which currently have little or no access.   For the avoidance of doubt, all of your therapy will be delivered by one of our therapists or PWPs and not an automated agent.

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.

In the event where a high level of clinical risk (of harm to yourself or others) is identified, and the level of risk increases to such a point that requires a further level of support than CBT can provide, then appropriate actions will be taken to ensure a referral onwards is facilitated for a participant to receive the most suitable level of care.

This study is funded by Ieso Digital Health. If you have any questions about this study, you can contact the Chief Investigator of this study Dr Michael Ewbank on 0800 074 5560 or email at m.ewbank@iesohealth.com. Alternatively, you may contact the Clinical Leads at Ieso Digital Health, Jack Southward and Shazna Khanom at clinicalleadership@iesohealth.com or 01223 608760.

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 directly identifiable data will never be included in any publication.

If the study results show that that our digital tools can be as effective in providing support for CBT as those that are used currently, we may explore the opportunity to roll out this service to a larger number of patients.

All study specific data and data duplicated for our research database will be stored separately from medical case files, be identified by a unique identification number and not contain directly identifiable information. 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, and completes the NHS Data Security and Protection Toolkit annually.

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.

All research data including personal data held separately from your patient file will be held for a minimum of 20 years in accordance with Medical Research Council guidance. Personally identifiable data collected as part of routine practice (standard of care) shall be retained for reference by you during your lifetime as explained in our therapy site privacy notices https://www.iesohealth.com/en-gb/therapy/legal/privacy.

Your treatment is confidential and your GP will not be informed that you are taking part in the trial. However, during registration you are asked whether or not you are happy for your therapist to share information with your GP, and if you consent we will make them aware of your entering and leaving treatment, with related questionnaire scores. Outside of this, there are two main reasons when we would be required to contact your GP. 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 follows accepted best practice/ regulations and 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.

You can change your mind about participating in this study at any time. If you no longer wish to participate in this study you should contact Michael Ewbank (Chief Investigator of this study) at m.ewbank@iesohealth.com or by phone on 0800 074 5560. Alternatively, you may contact the Ieso Digital UK Service Lead Jack Southward at j.southward@iesohealth.com or the Clinical Director, Shazna Khanom at s.khanom@iesohealth.com or by phone on 01223 608760.

If you change your mind your data will be removed from this study, up to and until the point where removing the data would seriously impair the research or render it impossible. However, your therapy case file 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.

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.

Study progress will be overseen and monitored by a study steering committee and patient panel. The steering committee will be formed by representatives of the sponsor, who will ensure the study is progressing according to plan and following relevant regulations and operating procedures. In addition to the steering committee, a patient panel was be set up for this study, composed of former internet enabled-CBT patients. These former patients will provide insight from a patient perspective and help steer the project.

If you have any complaints about this study you can contact the Chief Investigator Michael Ewbank at m.ewbank@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 1DS

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