SSRI Survey Study

Imperial College London Faculty of Medicine

You are being invited to take part in a research study involving patients taking SSRI antidepressants. Please carefully read the information below and take your time to think and discuss with others if you wish. It is important that you fully understand why the research is being done and what it will involve for you as a participant before you decide if you wish to take part.

The first half of this information sheet gives you some information on the purpose of the study and what will happen if you decide to take part. The second half gives you more detailed information relating to the conduct of the study itself.

If you feel there is anything you are unclear about or would just like some more information, please do not hesitate to contact us. Take your time to decide whether you wish to take part or not.

What is the purpose of the study?

This study is being run by the Centre for Psychedelic Research at Imperial College London, which is led by Dr Robin Carhart-Harris. The aim of the study is to collect data on the effects and effectiveness of selective serotonin reuptake inhibitor (SSRI) antidepressants, and related drugs, to treat a range of disorders, including depression and anxiety, and to compare these data to those of other interventions for depression. Online questionnaires will be used to collect data immediately after an SSRI is prescribed and then every week for 6 weeks after the start of the treatment. We would ideally also like to follow you up at 6 months and a year after treatment started to see how you are doing, we will therefore send you two email reminders at 6 and 12 months containing links to follow-up surveys, however, these are optional.

Why have you been chosen?

You have been chosen as a potential participant as we wish to monitor patients on antidepressants, from before they begin their medication and throughout their treatment, for a maximum of 12 months. We aim to recruit around 100 other participants like yourself to take part in this study.

What would taking part involve for you as a participant?

It is up to you to decide whether or not to take part. If you do decide to take part, you will be asked to give your consent at the bottom of this page, before you start the first questionnaire. If you decide to take part, you are still free to withdraw at any time without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive. Withdrawal from the study is possible through the link provided at the bottom of email reminders you will receive throughout the study to complete the next survey. You will then no longer be sent email reminders from us. If you wish for your data to be discarded from the study and to not be used in any data analysis, please request this through an email to the study coordinator. Please provide your full birth initials and the name of your GP/Psychiatrist within this email.

If you do decide to take part, you will be involved in the study for 1 year. This will involve completing a baseline questionnaire before you take your first dose of medication, then weekly questionnaires for 6 weeks. You will also be given the opportunity to complete two follow-up questionnaires at 6 months and 1 year.

The first questionnaire must be completed before you take your first dose of medication, this is important to allow us to collect data on the baseline measures that we can compare to data collected later. The first questionnaire is the longest you will do and will take approximately 23 minutes, if you are unable to complete any of the questionnaires in one run you can save your progress and complete it later. However, please make every effort to ensure the first questionnaire is completed before you start your medication.

You will then be sent one email every week for 6 weeks to remind you to complete the next questionnaire, please attempt to complete each questionnaire as soon as possible when you receive these emails - ideally that day or within a few days, please try to not let 7 days pass before completing each questionnaire. These questionnaires will take between 10-23 minutes each. After the final reminder email you will no longer be sent emails from us, unless you opt into receiving a summary on the study findings.

Throughout the surveys there may be certain topics that may cause you to feel uncomfortable or distressed. Matters including sexual dysfunction, suicidal thoughts and political perspectives are covered in some of the surveys. However, all questions asked throughout the entire study are optional and therefore you are free to skip any questions that you feel you do not want to answer. Skipping any questions will not prevent you from completing the rest of the survey or the entire study, nor will it affect your treatment throughout the study. If you feel that certain topics that are covered are too distressing or inappropriate, please do feel free to contact the study coordinator via the email located at the bottom of this information sheet to voice these concerns.

Confidentiality will only be broken under one circumstance. If you score highly on the questions related to suicidal thoughts, we will be required to report this to your GP/Psychiatrist. Your exact responses will not be shared with your GP/Psychiatrist nor will your scores on any other part of the questionnaire.

Your doctor will be paid for including you in this study.

What are the possible benefits of taking part?

We cannot promise the study will help you but the information we get from this study may help to advance the treatment of disorders such as depression and anxiety. You will receive a payment of £20 once you have completed your week 6 survey. You will find more information on how to request this payment at the bottom of this information sheet.

What if something goes wrong?

If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Dr Robin Carhart-Harris at r.carhart-harris@imperial.ac.uk). The normal National Health Service complaints mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Compliance Office.

Indemnity will be provided by Imperial College London.

Will your participation in the study and information you provide be kept confidential?

This study will endeavour to protect your confidentiality. We acknowledge that the collection of your age, gender, GP/Psychiatrist practice and name of GP/Psychiatrist and specific nationality could be used to break this anonymity, however, this will be stored securely.

If you wish for your information to not be shared with other researchers you can request this by emailing the study co-ordinator, providing your initials and General Practitioner's name in the email. Any data shared through publication of results will be fully de-identified and will not contain identifiable information.

For more privacy and data information please click here.

Information on Imperial College London’s retention periods may be found at https://www.imperial.ac.uk/media/imperial-college/administration-and-support-services/records-and-archives/public/RetentionSchedule.pdf and further transparency wording can be seen here.

You can find out more about how we use your information by contacting the Principal Investigator [Dr Robin Carhart-Harris at r.carhart-harris@imperial.ac.uk].

Payment Information for Patients

To allow for the correct payment to be made please complete Section A of the form found here. Please then send this form to the study coordinator at hmd17@ic.ac.uk. The remaining sections will be completed by study researchers. Please only send this form to the study coordinator once you have completed your final week 6 survey.

This study is being funded by Patrick Vernon, film maker and social activist who has an interest in the treatment of mental health disorders.

This study was given a favourable ethical opinion for conduct in the NHS by the Fulham Research Ethics Committee and the Health Research Authority.

Any Issues?

If you require any further information please do not hesitate to contact the study coordinator Hannah Douglass (hmd17@ic.ac.uk) with any questions. To speak to a member of the study team the 24-hour contact number is 07341268104.

You can withdraw from this study at any time by clicking "withdraw from the study" in the reminder emails you receive from us, and you may also request that your data will be discarded at any point by contacting the study administrator via hmd17@ic.ac.uk

Thank you for reading this and for taking part in this study, your participation is greatly appreciated.

(Participant Information Sheet, Version 5, 16/03/20)