Participant Information Sheet
Study: What support do individuals with experience of psychosis want when discontinuing neuroleptic medication: A Delphi method study
Invitation: We would like to invite you to take part in a research study. Before you decide whether or not to take part, please read why the research is being done and what it would involve for you. Please take time to read the following information carefully. You can also speak to others about the study if that is helpful. The study is being conducted by a trainee clinical psychologist as part of their doctoral training.
Research Summary: The study involves asking people with experience of psychosis about what support they believe is wanted when discontinuing neuroleptic medication. We hope to gain a consensus about what support is most important.
What does the study involve? The study involves completing a 30 minute online questionnaire to rate statements about the type of support that is wanted when discontinuing neuroleptic medication. You will be asked to rate the statements based on their level of importance. Approximately one month later, you would be asked to complete another online questionnaire to rerate some of the same statements again, that did not reach consensus about their level of importance.
It is hoped that the findings of the study will help us to understand how support for individuals discontinuing antipsychotics can be provided in the future.
Why have I been invited? We are looking for participants who have received a diagnosis related to psychosis and has either stopped the antipsychotic medication they were prescribed or has made at least one previous attempt at stopping.
Do I have to take part? Taking part in the study is voluntary and you do not have to take part. If you decide to take part and complete the consent form but change your mind later, you can withdraw from the research before January 2019 without giving a reason and without any consequence. If you withdraw from the research, you can choose whether your data is destroyed. However, it is possible that if your online questionnaire has already been analysed, your ratings may have already been used to generate the second online questionnaire.
Who is carrying out the research? This research is being conducted by Annabel Green who is a Trainee Clinical Psychologist at the University of Manchester. The project will be supervised by Dr Sara Tai (Consultant Clinical Psychologist) a Senior Lecturer working at the University of Manchester, as well as Mrs Yvonne Awenat, a Registered Nurse and Clinical Research Fellow at the University of Manchester. The research is being sponsored by the University of Manchester.
What happens if I take part? If you took part in the study, this is what to expect:
- We will arrange to talk to you about the study over the telephone and give you a chance to find out more and ask any questions
- You will be given a minimum of 24 hours to think about whether you want to take part in the study.
- If you decide you would like to take part in the study, you will be asked to sign a consent form stating that you want to be involved. You will also be asked to fill out a short demographic questionnaire asking for information like your age, gender, how many attempts you have had at discontinuing neuroleptic medication. This helps us to ensure we include a range of different people within the research.
- You will then be emailed an electronic link which will enable you to access the online questionnaire. You will also be emailed an instruction document on how to complete the questionnaire. The online questionnaire should take approximately 30 minutes to complete.
- The online questionnaire will ask you to rate statements about the type of support that is wanted when discontinuing neuroleptic medication, based on their level of importance.
- Approximately one month later you will be asked to take part in another online questionnaire, to rerate some of the statements.
- When the research is completely finished (approximately February 2019) we will send you a summary sheet of the findings if you would like us to do so. In order for us to be able to do this we would need to retain your contact details for 3-6 months after the study has ended, but these would be stored as a password protected file on the University of Manchester’s secure network and destroyed once the summary has been sent to you.
Payment and expenses? At the end of the questionnaire, you will have the option to receive £5 for the completion of each of the online questionnaires as compensation for your time. In order to receive the £5 you will need to click a button to confirm that you are happy for your email address to be sent to the researcher so that they can contact you about payment. The researcher would not be able to identify which data was yours as it would not be linked to your email address.
Will my information be kept confidential? We will provide you with a unique code number so we do not have to use your name on any of the questionnaires. To ensure the study is being carried out properly, individuals from the University may access study data. With your permission, the information they look at may include personal data but the individuals accessing the data will have a duty of confidentiality to all research participants. The results of this project will be written in a research report, which may be published in a scientific journal. We will use the analysis from the online questionnaires but no personal details will be used.
Data from the study will be kept for a minimum of 5 years and might be used for future research studies but would still remain anonymous.
Are there any potential benefits to taking part? There are no immediate benefits to you by taking part. It is hoped that the study will allow you an opportunity to voice your opinions.
Are there any potential risks? We do not anticipate any risks.
What if there is a problem? If you have a concern or minor complaint about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact details provided at the top of this document). If you wish to make a formal complaint or if you are not satisfied with the response you have gained from the researchers in the first instance then please contact the Research Governance and Integrity Manager, Research Office, Christie Building, University of Manchester, Oxford Road, Manchester, M13 9PL, by emailing: email@example.com or by telephoning 0161 275 2674 or 275 2046.
Who has reviewed the study? This study has been reviewed and accepted by the Manchester University Research Ethics Committee.
Who do I contact? If you have any questions about the study or would like to take part please contact the researcher, Annabel Green on the details below. Alternatively, you can contact one of the research supervisors – Dr Sara Tai firstname.lastname@example.org) or Yvonne Awenat (Yvonne.Awenat@manchester.ac.uk)
Many thanks for your interest.
School of Health Sciences
Division of Psychology and Mental Health
2nd Floor, Zochonis Building, Brunswick Street, Manchester, M13 9PL