REC Reference Number: HR-17/18-5166
YOU WILL BE GIVEN A COPY OF THIS INFORMATION SHEET
We would like to invite you to participate in this original research project, funded by ‘MQ: Transforming Mental Health’ charity. You should only participate if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information.
This study is designed to help us understand why some people find it difficult to stop thinking repeatedly about negative topics. This negative thinking can take the form of worry (for example, thinking about how things might go badly in the future) or rumination (for example, thinking about upsetting things in the past or why you are feeling so bad). Most people worry or ruminate from time to time, but usually this passes fairly quickly. However, some people find that once negative thinking has started, it is very difficult to stop. People with Generalised Anxiety Disorder (GAD) and/or depression often describe worry and rumination as dominating their everyday thoughts, without being able to stop thinking this way. Research studies have shown that, rather than helping to resolve personal problems, focusing on negative topics in this way usually causes anxiety and depression to get worse and to persist longer. However, we know very little about why or how some people are able to control negative thinking while others find it so difficult. In the present study we hope to learn more about what can make negative thoughts so persistent and what people can do to prevent such thoughts getting out of control. Understanding these issues better is important if we are to develop more effective psychological treatments for GAD and depression in the future.
To take part in the study, we are looking for people who:
If you are interested in taking part in this study, you will first be asked to complete some questionnaires which will help us begin to decide if you are suitable for the study. Please note that after completion of these questionnaires, you are under no obligation to take further part in the study if you do not wish to do so. If you wish to withdraw after completing the questionnaires please contact a member of the team so they can dispose of them immediately. The initial questionnaires you complete provide us with some indication if the study may be suitable for you to participate in. We will then arrange a phone call with you (Video Skype is also possible if you prefer) once you have completed the initial questionnaires, which will last up to 30 minutes. You will be asked some questions about your mood, anxiety, and their impact on your life. With your consent, this phone call will be audio-taped for later categorisation by a member of the research team (no identifying information about you will be included in the recording). If at this point you don’t meet the study criteria, we will let you know and you will be given £7 in vouchers for your time.
If you do meet our criteria, you will be invited to take part in our study. The study is entirely online, so you will not be required to attend any visits with us in person. The study involves logging in to our study website, completing an initial assessment session, and then completing 10 assignments lasting 30 – 35 mins (the first assignment lasts ca. 45 mins as it includes an extra task) over the course of the following three weeks. At the end of the three weeks, there will be a second assessment session, also online. And with your consent, we will contact you one month and three months after the second assessment session to complete two final online questionnaires for us.
Please note that you will not be able to withdraw any data you have contributed to the study once you have completed the initial assessment session, as it will be analysed in anonymised form, meaning it cannot be traced back to you.
To contribute towards your time, you will be given £80 in vouchers after completing the second assessment session and receive a further £20 of vouchers after you return your completed 1-month follow-up questionnaires and another £30 when you return your completed 3-month follow-up questionnaires. This means you will receive £130 in vouchers for your participation in the study.
The initial assessment session
This session involves completing a set of questionnaires covering questions about your mood and worries, and tendency to ruminate, and doing several tasks. In one task, you will unscramble some sentences so they make sense, which you’ll complete while trying to remember a string of 6 digits. Some of these sentences may be positive, and some may be negative. In the next task, you will be asked to read scenarios and then be presented with a number of sentences. You will rate how similar the sentences are to the original scenario. You will also be asked to identify a topic that you currently worry or ruminate about, and to think about this topic in the way you usually do. In another task, you will be asked to focus on your breathing for 5 minutes, and from time to time briefly indicate what you’re thinking about.
The 10 assignments
In the first assignment, you will then be introduced to the tasks we would like you to do. The main task involves listening to short scenarios via headphones, thinking about them in certain ways, and answering questions about them. You will practice this task before completing it for the first time. There will also be a few other short tasks. The subsequent nine assignments will be same as the first one, just minus the practice at the beginning. The assignments can be done on a laptop, tablet, or computer and will need to be completed at a time when you will not be disturbed. Each assignment will take about 30-35 minutes (except for the first one, which takes ca. 45 mins). With your consent, you will receive reminders (e.g. by email) to complete your assignments. We will also be in contact (by email, phone or text, depending on your preference) over the course of the three weeks to find out how you are getting on.
Second assessment session (after completing the ten assignments)
This session will involve the same questionnaires and tasks as the initial assessment session, and you will be asked about your experience in taking part over the past three weeks. After you have completed this session, you will receive the first instalment of vouchers.
Follow up questionnaires (one and three months later)
One month and three months after the second assessment session, you will again be asked to complete some questionnaires. After completing the last set of questionnaires, you will be fully debriefed about your participation in the study and will receive the second and third instalment of vouchers. Although the researchers will not be able to give you individual feedback, you will receive an overview of the study.
The study involves thinking about some current worries and things that you ruminate on. Some people might find some of these tasks uncomfortable or mildly distressing, but that feeling will go away once the task stops and will have no long-term impact. If the study brings up any concerns, you will have the opportunity to discuss them with the researcher over the phone or via email. Participating in the study will involve some of your time, as described above, to complete the assessment sessions, assignments and the follow-up questionnaires. You may find completing the study slightly tiring, but you can arrange with the researcher a time that suits you best and they can help you work out a time to do your assignments that works best for you. Furthermore, you will be free to withdraw from the study at any point if you wish to do so.
We hope that you will find it interesting to take part in this research. Also, the information we get from this study should help us to understand more about why some people cannot stop worrying or ruminating and how we may be able to help them overcome this. This research is part of a wider programme designed to develop better treatments for people who suffer from anxiety or depressive disorders. So by taking part you will be contributing to a research effort aiming to improve methods of helping those who suffer from these debilitating conditions. Because research of this kind addresses questions to which we do not yet know the answers, it is impossible to know if taking part will be personally helpful, although we certainly hope that some of the techniques involved will help participants to worry and ruminate less. Finally, we are happy to provide full information about the results of the study in which you took part, so that you can be informed of any methods that proved especially helpful. If you would like a copy of the research findings, please let the researcher know, and we will arrange for a copy of the final written report to be sent to you as soon as it is available.
Information which is collected about you during the course of the research, including audio recordings, your answers to questionnaires and the online tasks, will be kept strictly confidential. This means you will be given a participant number and that the only way to identify you will be by your numerical ID, to ensure anonymity. All information will be kept strictly confidential unless any information is disclosed which could seriously affect the welfare of yourself or others, in which case a third party may have to be contacted for legal reasons.
These data will be stored securely in anonymised form on a password-protected computer in King’s College London for up to seven years. Data will only be seen by members of the research team.
The findings will be used to improve psychological treatments for GAD and depression. The results of the study will be published in a peer reviewed journal, presented at conferences and discussed at other public events. Individual data will not be reported and you will not be identified in any report or publication.
The research has been approved by the Psychiatry, Nursing and Midwifery (PNM) Research Ethics Subcommittee (RESC) at King's College London (ref no: HR-17/18-5166).
It is up to you to decide whether to take part or not. If you decide to take part you will have access to this information sheet and will be asked to complete an informed consent form before you start the first assessment session. If you decide to take part you are still free to withdraw at any time and without giving a reason.
If this study has harmed you in any way, you can contact the Chair of the Psychiatry, Nursing and Midwifery Research Ethics Subcommittee on email@example.com. For general queries about the study, please contact Dr Charlotte Krahé or Jessica Whyte at firstname.lastname@example.org or on 0207 848 0318, or at the following address: Department of Psychology, PO 77, Institute of Psychiatry, De Crespigny Park, London SE5 8AF.