The iWaWa Study

Welcome and thank you for your interest in testing iWawa - an online program for mums who feel anxious or worried in the 1st year after childbirth.

FAQ

Frequently Asked Questions

 

You are invited to take part in a research study testing a new program to reduce worries after childbirth. Before you decide we would like you to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully and discuss it with others if you wish. Contact Miriam T. Ashford if there is anything that is not clear.

What does iWaWa stand for?
iWaWa stands for internet-based What Am I Worried About

What is the purpose of the study?
This study is part of a PhD project (Miriam T. Ashford) and tests a new website-based program for women who experience anxiety after childbirth. The program is called What Am I Worried About (iWAWA). In this program you will learn about anxiety and worries experienced by other mothers and practice activities to overcome those. We want to know if you like the program and if it lowers your anxiety.

Why have I been invited?
We are inviting 72 first-time mothers living in England who gave birth within the last 12 months and are feeling anxious. You can take part in the study if you report moderate to high anxiety symptoms on an anxiety questionnaire, are aged 18 or over, and fluent in English.

Do I have to take part?
No, it is up to you to decide to join the study. If you do decide to take part, we will then ask you to agree to a consent form. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive or disadvantaged in any way.

What will happen if I take part and what do I have to do?
First you will be asked to fill out an online questionnaire asking questions about you and how you feel (approx. 15 minutes to complete). This will determine if you can take part in the study.

If you can take part, you will all get access to the program, but the time when you get access depends on the group in which you are put into by us. Sometimes we don‘t know whether using a program helps with reducing anxiety. To find out, we need to compare the program against no treatment. We will put you into one of the following two groups. In one group you will get access to the program right away (intervention group) and the other group you will wait for eight weeks to get access to the program (waiting group). The results of both groups are compared to see if the program works. To try to make sure the groups are the same to start with, each participant is put into a group by chance (randomly). The randomisation is done by a computer which has no information about you – i.e. by chance. The chance of you being in each of the two groups is 50% (the same as if a coin was tossed).

The intervention group:
You will be asked to work through the program website from home for eight weeks. This program has nine sessions in which you will learn about anxiety and common worries in the time after giving birth and practice activities to overcome those. The sessions are designed to take approximately 30 minutes to an hour, but it is up to you how much time you spend on each session. You can do a session in one go or dip in and out of the sessions. There will be an opportunity to speak to a support coach every week about what you have learned in the program. These phone calls are optional and can be as short as you want, but a maximum of 30 minutes. After each session you will be asked to answer two questions about your experience with the session. The program will record online how you used the program (number and time of program visits).
Besides working through the program, you will also be asked to fill in two further online questionnaires. One questionnaire will be immediately after the eight weeks of using the program and will ask you how you feel and about your experience with the program and should take no longer than 15 minutes. The second questionnaire will be at four weeks after the end of the program and again ask you about how you are feeling (approximately 5 minutes). The figure below gives you an overview of the different stages of the study and what you are being asked to do. After completing the treatment the researcher will contact to invite you to participate in an interview about you experience with the study and the program (optional). Throughout the study you will be in contact with the research team on the phone or via email/text message.

 

Picture_study flow

Waiting group
In this group you will get access to the program after eight weeks. After the eight weeks, you will be asked to fill in an online questionnaire, which will ask you how you feel and this should take no longer than 5 minutes.
Throughout the study you will be in contact with the research team on the phone or via email/text message.

What are the possible disadvantages and risks of taking part?
This study does not involve any drugs, so the risk for you and child is very low. However, there is the chance that you may experience your worries or overall wellbeing to get worse. If you feel worried, please contact your GP or health visitor. You can also get help from the following services. Here are links to websites and contact details of organisations which deal with postpartum or general mental health:
• Association for Postnatal Illness – Get help: http://apni.org/need-help-now/
• MIND – Infoline: http://www.mind.org.uk/information-support/helplines/

What are the possible benefits of taking part?
You will be able to learn about how to manage your worries. We cannot promise the program will help you, but the information we gain from this study may help to improve and develop more suitable treatment programs for women who experience similar anxieties as you do.

What will happen if I don’t want to carry on with the study?
If you withdraw from the study, the date of your withdrawal will be recorded and we will approach you to ask for the reason for your withdrawal. It would be helpful for us to know your reason, but answering this question is entirely optional. We will use the data collected up to your withdrawal. However, you can request the destruction of your data by contacting Miriam T. Ashford.

What will happen when the research study stops?
The program will unfortunately not be available to you study participation has finished.

Will my taking part in the study be kept confidential?
Yes, all information which is collected about you during the course of the research will be kept strictly confidential, stored securely and no one will be told about you testing the program. You will create a unique identification code which will be used for all study documents and database. The document containing your identification code and your actual name will be stored securely and separate from any other data and documents. Access to the study data will be restricted to the researchers involved in this study. Your data will be stored securely for a minimum of three years after the end of the study at City, University of London and then safely be destroyed. This study complies with the current revision of the Declaration of Helsinki (last amendment October 2008) and with MRC Guidelines for Good Clinical Practice in Clinical Trials (1998).

What will happen to results of the research study?
Findings will be presented at relevant conferences, published in relevant peer-reviewed journals, and be included in the PhD thesis of Miriam T. Ashford. You will not be identifiable from any report.

Can I contact to researchers responsible for this study?
Yes, you can contact the responsible researcher with any kind of questions or comments at any time before you decided to take part, during the study and after after taking part in the study. Contact details can be found here.

What if there is a problem?
If you have any problems, concerns or questions about this study, you should ask to speak to the researchers who will do their best to answer your questions (E-mail: miriam.ashford@city.ac.uk phone: 020 7040 5775). If you remain unhappy and wish to complain formally, you can do this through the University complaints procedure. To complain about the study, you need to phone 020 7040 3040. You can then ask to speak to the Secretary to Senate Research Ethics Committee and inform them that the name of the project is: Feasibility trial of a web-based intervention for maternal postpartum anxiety
You could also write to the Secretary at:
Anna Ramberg, Secretary to Senate Research Ethics Committee
Research Office, E214, City, University of London, Northampton Square, London, EC1V 0HB
Email: Anna.Ramberg.1@city.ac.uk
City, University of London holds insurance policies which apply to this study. If you feel you have been harmed or injured by taking part in this study you may be eligible to claim compensation. This does not affect your legal rights to seek compensation. If you are harmed due to someone’s negligence, then you may have grounds for legal action.

Who is organising and funding this study?
This study is organised and funded by City,  University of London.

Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the Dulwich NRES Research Ethics Committee.

Is this research study registered at an online trial database?
Yes, this study is registered at the ClinicalTrials.gov database.
City University London. Website-based self-help for women With anxiety after childbirth. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2015- [cited 2015 June 06]. Available from: http://clinicaltrials.gov/show/NCT02434406 NLM Identifier: NCT02434406.

 

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