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What is PND
What is the purpose of the study
Why have I been selected to take part in the study

Do I have to take part
What would taking part in the study involve
Who would know about me taking part in the study
What are the benefits of taking part
What would happen to the information I provide during the interview
What would happen to the video recording of me playing with my baby

What will happen to the results of the research study
Who is organising and funding the research

Who has reviewed the study
What if I want further information about the study

   

What is PND

Postnatal depression (PND) is a condition affecting around 13% of women following childbirth. It produces symptoms such as feeling sad, confused, unable to sleep, anxiety and suicidal thoughts. Research has shown that psychological factors such as feeling isolated, lack of an intimate friend, and low self-esteem are important contributing factors. PND has important health consequences for the mother and the development of their baby.

What is the purpose of the study

The aim of this study is to pilot a telephone support service that is being delivered by specially trained peer supporters who are all mothers who have recovered from postnatal depression.  This service was evaluated in Canada and was shown to be effective in reducing symptoms of depression among mothers experiencing postnatal depression.  We have adapted this intervention for use in the UK, and are now conducting a study to explore whether it improves outcomes for new mothers and their babies.  

Who should take part in the study

We are inviting all women who have a score of between 13 and 19 on the Edinburgh Postnatal Depression Scale (EPDS) to take part in this study. We are not inviting women with a score below 13 to take part becasue this suggests that there are no symptoms of depression present or they are very mild.  We are also not inviting women with a score of 19 or above to take part because this indicates the presence of serious depression for which women should be receiving specialist care from their GP and health visitor.  If you were interested in taking part in the study, we would ask you to complete the online (EPDS) questionnaire before you consented to take part, to ensure that your score was within this range.

Do I have to take part

If you were eligible to take part having completed the Edinburgh Postnatal Depression Scale, it would then be up to you to decide whether or not to go ahead.  This information is provided to help you to make that decision. Even if you decided to take part, you would still be free to withdraw at any time and would not have to give a reason.  This would not affect the care you received from your GP practice.  Your doctor would not be upset if you decided not to take part.

What would taking part in the study involve

If you agreed to take part, you would be allocated randomly to one of 2 groups in the study. We do this by a method that is similar to tossing a coin. If you were allocated to the Intervention Group you would receive a series of phone calls from a trained peer supporter over a 4 month period or until such a time as you both decided to end the calls (the times of the calls would be arranged between you and the supporter). You would also be asked to complete a questionnaire at three points in time. At the end of the study a researcher would also invite you to take part in a brief interview to ask you some questions about how whether the telephone support had been helpful, and in what ways the service could be improved. This call/visit would be tape-recorded with your permission. The tape would not have your name on it, only a number. Any information you provided would be treated as confidential and anonymous. Your participation in this study would not affect any other support that you were receiving.

If you were allocated to the Standard Treatment Group you would continue to receive standard care from their GP and health visitor, and would also be contacted by a researcher and asked to complete the study questionnaire at three points in time.

With your permission we would also like to make a short video recording (3 minutes) of you playing with your baby.  There would be no identification details attached to any DVD, and you would be provided with a copy of the DVD.

 Who would know about me taking part in the study

The research team would know whether you had agreed to take part in the study. With your permission, we would also like to let your GP and your health visitor know that you are taking part. 

Any information that you provide us would we be treated as confidential and would not be shared with anyone outside the research team unless required by law under the terms of the Children Act (1989).  This means that we would only divulge information that you had provided to us if there were concerns about the safety of a child.

When writing up the findings of the study the researchers would take care to ensure that they did not reveal the identity of participants, and any quotations that were used for the purpose of reports or presentations would be anonymous. 

What are the benefits of taking part

We cannot be sure if there will be any benefits of taking part in this study, even if you were allocated to the Intervention group.  The aim of the study is to see if the telephone support leads to a reduction of symptoms of depression. We are also interested in which the additional telephone support has any benefits on the wellbeing of babies, by improving the mental health and wellbeing of the mother.

While your participation might not have a direct benefit for yourself it could help other mothers with postnatal depression in the future by helping to improve and refine the services.

What would happen to the information I provide during the interview

The Questionnaires that you would be asked to complete for us at three points in time would not have any means of identifying you. Each questionnaire would be given a study number so that we could match them. They would be kept at the Warwick Medical School, in a locked cabinet, in a locked room, and would be destroyed after a period of 3 years.

If you were in agreement to taking part in an interview, this would be recorded on an audiotape, which would be stored with your questionnaire, and would only be identifiable via the study number. The audiotapes would only be used for the purposes of this study, and would be destroyed after a period of three years. Should you not agree for the interview to be recorded, the researcher conducting the interview would take notes. Anonymous quotations might be used for the purpose of reporting the findings of the study or presentations to professional audiences.

If you were in agreement to us making a short video recording (3 Minutes) of you playing with your child, this would be stored as above; it would only be used for the purpose of this study, and would not be shared with any person outside the research team. We would provide you with a copy of the video that we made.

What will happen to the results of the research study

The results of the study would be written up in a final report and the results may also be written up in professional journals. If you were interested, we would be happy to provide you with a copy of the report.

What happens now

Once you have read through this information, you will be able to complete the online questionnaire (EPDS).  Within one week of completing the questionnaire, a researcher would contact you by telephone to answer any questions you may have, to ask if you would be interested in taking part and whether you would be eligible. If you are not interested in taking part, we would thank you for your time and no other contact will be required. Your decision would not affect any services that you would be currently receiving.

If you were not eligible to take part, we would tell you and if necessary suggest any further support that might be available. This decision would not affect any of the services that you were currently receiving. We would also request your permission to contact your GP/health visitor to tell them about this outcome.

If you were eligible to take part we would send you a consent form and a further questionnaire by post. When we had received these back from you in the prepaid envelope, we would allocate you (by a procedure that is similar to tossing a coin), into the Intervention Group or the Standard Treatment Control Group. We would then ring you and tell you which group you were in.

Who  is organising and funding the research

Warwick West Midlands Primary Care Research Consortium has provided funding to conduct this study.  Researchers from The University of Warwick, together with health visitors from South Warwickshire PCT, are organising and conducting the study.  The study is being conducted under the direction of Prof. Jeremy Dale and Prof. Jane Barlow, Warwick Medical School, University of Warwick, Coventry, CV4 7AL.  The study researcher is Mrs. Sukhdev Sembi.

Who has reviewed the study 

The study has been reviewed and agreed by Warwickshire Research Ethics Committees (number 08/H1211/94).

 What if I want further information about the study

If you want any further information about the study you can telephone the study researcher Mrs Sukhdev Sembi on 02476 150508.
Thank you for taking the time to read this information sheet. If you would like to take part in the study, please complete the questionnaire, which you can access by filling the form below and pressing submit.

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