Study Information

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Please read on to find out about how you may be able to help with important research.

What are the objectives of the research?

Antidepressants affect people differently. With your help, we aim to develop a tool that can be used by doctors to improve their ability to identify the best treatment for each unique person – helping people get better, faster.

What will happen if I volunteer?

To sign-up for the study you will be asked to: dav

 

1. Submit a photograph of a valid prescription for an antidepressant. (Note that the date, drug dose, and drug name must be clearly visible; you may obscure your own name)

 

2. Provide information relating to:

  • Your treatment plan (start date, dose etc.)
  • Past and present medications.
  • Your age.
  • Your symptoms (3 questionnaires).
  • An email address for us to contact you on.

If you are eligible for the study, you will be asked to complete a series of measurements over the course of 3 weeks via the internet:

Week 0:

Complete a series of computer games and puzzles that assess various aspects of cognition, answer sensitive questions pertaining to symptoms of mental health disorders and aspects of your lifestyle, provide additional demographic and treatment information. Duration: less than 2 hours (take as many breaks as necessary).

Check-in at week 1, week 2:

Answer some questions about how you are feeling and update us on any changes to how you are taking your medication. Duration: 10-15 minutes each week.

Week 3:

Complete a similar series of computer games and questions to those completed in Week 0. Duration: less than 1.5 hours (take as many breaks as necessary).

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Some of the games we ask you to play at ‘Week 0’ and ‘Week 3’.

Am I eligible?

To be eligible for this study you must:

  1. Be about to start taking a new antidepressant (for the first time OR about to switch to a new one).
  2. Be taking the antidepressant for the treatment of a mental health problem.
  3. Not be currently taking any other medications for mental health problems.
  4. Not have taken any other medications for mental health problems in the past 4 weeks.
  5. Be aged between 18-70.
  6. Be fluent in English.

Are there any risks involved in participating?

The risks associated with participating in this study are minimal to non-existent.

However, it is possible that you might find the sensitive nature of the questions upsetting. In particular, we would like to advise you that one of the questionnaires will require you to indicate whether or not you experienced any abuse (physical or sexual), trauma, or neglect during your childhood. Before agreeing to participate, we would like you to consider whether you will be willing to answer these potentially sensitive questions. We will provide information about international resources, links to useful support services, websites and hotlines that you can access if you find these questions upsetting.

Most importantly, this study is naturalistic in design. That means that we collect measurements from participants as they go about their lives as normal, without interference. If you decide to change your treatment mid-way through this study or decide to stop taking your treatment entirely, this does not affect your participation in this study in any way – you can continue to the end as receive payment as usual. We are just as interested in people who decide to stop taking treatment as we are in people who take it all the way through. All we ask is that you keep us up to date on what you are taking each week!

Are there any benefits to participating?

This study will not benefit you in any direct way therapeutically. However, we hope to use your data to develop a tool that can match specific treatments to specific individuals in the future, and in that way your contribution will benefit others.

Will the research team take responsibility for monitoring my treatment and care?

No. The researchers conducting this study are not responsible for monitoring your treatment or changes in my mental health status, e.g. worsening of symptoms. The prescribing clinician should be contacted with all questions pertaining to your continued care, including any adverse effects associated with taking antidepressant medication and decisions regarding continuation or cessation of treatment. The research team will never interfere with or monitor treatment in any way, and will never provide advice about your care.

What happens if I decide not to participate or leave the study early?

It is entirely your choice whether you participate in the study. You can choose to leave the study at any stage. You can also choose to withdraw your data at the conclusion of your participation if you so wish, up until the point that my data has been analysed and a report based on the data has been submitted.

What will happen to my data?

Information from this study will be kept strictly confidential and no identifiable information (i.e. your name, contact information, or date of birth) will be made available to any person outside the research group. Also note that, at no stage in this study will you be asked to provide your name.

Your contact information will be stored in anonymised, encrypted form in a password-protected computer. We will aim to present and publish our results in conferences and scientific journals and to share the raw anonymised data collected in this study with other researchers for follow-up analyses. This will be done by linking your data to a unique study ID, with all identifiable information removed – specifically your name, contact information, and date of birth will be removed. Under the Freedom of Information Act 2014, you will have access to any information stored about you in relation to the current study for up to 10 years after you provided it.

Who is running this study?

The study is being conducted by a research team based at the Trinity College Institute for Neuroscience at Trinity College Dublin in the Republic of Ireland. The study has received ethical approval from the School of Psychology Research Ethics Committee at Trinity College Dublin and was additionally internally and externally reviewed by the study funder: MQ, transforming mental health:

https://www.mqmentalhealth.org/research/profiles/predicting-how-well-anti-depressants-work

Who can I contact if I have questions, comments or complaints about this study?

Dr Siobhan Harty (Researcher)
Trinity College Institute of Neuroscience,
Trinity College Dublin, Dublin 2, Ireland
Email: hartys1@tcd.ie
Tel: +353 1 896 8506

Dr Claire Gillan (Principal Investigator)
Trinity College Institute of Neuroscience,
Trinity College Dublin, Dublin 2, Ireland
Email: gillancl@tcd.ie
Tel: +353 1 896 8528

How can I proceed to sign-up?

You can proceed to provide your consent to participate and sign-up at our study website:

AntidepressantResearch.com

 

 

 

 

 

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