How the study works

You may have already received information about the study, or you may have seen a poster advertising the study in your local area. The next step is for you to read the information sheet (PDF , 104kb) which will help you to decide whether this is a study you would like to take part in.  You can discuss the study with your friends and family too, Please feel free to contact the research team if you have any questions about the study.

If you would like to take part, you will need to complete a consent form (PDF , 701kb) and return this to the research team. You will then receive a telephone call from a researcher who will ask you a few more questions to see  whether the study may be suitable for you. 

If the study is suitable for you and you are still interested in taking part, you will be asked to complete a questionnaire about yourself. We can arrange for a researcher to ask you these questions over the telephone, or we can send you the questionnaire to complete and post back to us in a prepaid envelope. You will also be asked to complete a similar questionnaire four months after you have been in the study. You may also be asked if you would like to take part in a feedback session to discuss your views about mental wellbeing and the new way of giving support via your community pharmacy.

Even if you agree to take part in the study, you are still free to stop at any time without giving a reason. The standard of care you receive from your pharmacy or GP won’t change if you decide not to take part, or if you decide to stop once you’ve started. When the study has finished and the results published, a summary of the results will be made available to you.

Community pharmacies are now providing a range of health support services and the new support (Pharmacy Support) we are looking at in the study is similar to these. We don’t yet know if this new type of support is any better than the care already offered. We need to compare the two methods of giving care to see if there is a difference. This will mean that half the people in the study will be offered this new form of support and half will get usual care. Usual care means you will continue to receive your usual NHS care. A computer will chose which group you are in- this is called ‘randomisation’. It is a bit like rolling a dice to decide and it means you have an equal chance of being in either of the two groups. No treatment will be withheld and both groups will continue to receive all the care and support they usually do whilst taking part in the study. 

If you are allocated to the Pharmacy Support group a, Healthy Living Advisor from your pharmacy will work with you to plan changes that aim to improve your mood and overall wellbeing. A Healthy Living Advisor will contact you to arrange a convenient time to meet you or speak with you.

The first meeting may take place at your pharmacy or over the telephone. After this, you will speak with your Healthy Living Advisor up to a total of six times, normally on a weekly basis, over a period of four months. You will be provided with a booklet to help you think about your difficulties and what you may be able to do to improve some of them. During your weekly sessions, your Healthy Living Advisor will discuss this with you and a range of issues you may have. Each time you speak it will last about 15-20 minutes. At the end of each session, you and your Healthy Living Advisor may plan some things for you to do before you next speak.

If you are allocated to the usual care group, your care will continue as normal. You will still play a vital part in the study by being in this group. We will still ask you to complete all of the study questionnaires. The information you give us will enable us to see whether the Pharmacy Support gives better results than the usual care people generally receive. To do this, it is important that we compare the two different groups. 

We will treat any information you give us in confidence and store all your information safely and securely. We will not mention your name in any publications about the study and we will make sure that no individuals can be identified in the study results.

We will tell your GP if you agree to take part in this research. We will also ask for your permission to get in touch with your GP if we have any concerns about your health while you are helping us with the study.

Privacy Notice: How we use your research data

http://www.tewv.nhs.uk/site/content/About/Privacy-Notice

We cannot promise that taking part in this study will help you. Taking part could help improve the support offered to people suffering from low mood in the future. The type of support we are offering has been shown to help people in GP practices. You may be offered this additional pharmacy support which is not usually available to people from their community pharmacy. 

Taking part in this study will take up some of your time. It takes times to complete the study questionnaires. People in the Pharmacy Support group will spend some time reading the booklet, speaking with a Healthy Living Advisor and working through the activities.