GRACE Intervention Study

1. Invitation Paragraph

You are being invited to take part in a research project. Before you decided it is important for you to understand why the research is being done and what 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. Take time to decide whether or not you wish to take part. Thank you for reading this.

2. What is the project's purpose?

This project is part of the MSci module PSYC0181 Research Project. It aims to test whether a novel tinnitus therapy called GRACE can help people with tinnitus feel less distressed by their symptoms. The therapy encourages participants to notice and reinterpret stressful sensations in a calmer, safer way. By doing so, it may improve acceptance of tinnitus and reduce the psychological discomfort.

3. Why have I been chosen?

The research is for individuals aged over 18, experiencing at least moderately distressing tinnitus, without currently undergoing any other therapy or treatment for tinnitus. Additionally, participants need to have sufficient English language and hearing ability to participate. To ensure you meet our inclusion criteria, we require that you complete our screening questionnaire to confirm your participation in the study.

4. Do I have to take part?

It is up to you to decide whether to take part. You will be able to ask questions about the study before deciding whether to participate. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. You can also choose to withdraw at any time without giving a reason. If you choose to withdraw you will be asked what you wish to happen to the data, you have provided up to that point and provided the choice to withdraw your data from being included in the analysis and report.

5. What will happen to me if I take part?

If you choose to take part, you will first be asked to provide consent to participate before completing a set of questionnaires. The questionnaires will include questions on various topics, such as your background (age, gender, emails, ethnicity), your level of tinnitus suffering and depression, anxiety level. It is possible that we may find you are not eligible for the study upon completing these questionnaires, in which case we sincerely thank you for your time and interest in our study.

Once your participation in the study is confirmed, you will have the option to complete the intervention. The intervention is divided into five modules. Each modules includes two components: a short teaching summary video last for 10 minutes, delivered by the researcher and supervised by Dr Florian Vogt, a clinical psychologist specialising in tinnitus treatment, which introduces the key concepts from the corresponding GRACE Method Workbook module; and a daily 10-minute guided meditation practice, also recorded by Dr Vogt, designed for participants to use once per day over the three-day period and begin immediately upon starting the stage. You will also be asked to rate your level of tinnitus suffering, depression, anxiety and how annoying your tinnitus is at the end of every three days module. You are encouraged to complete the intervention feedback form as well. The intervention will last for 15 days (3 days per intervention module for five intervention modules).

6. What are the possible disadvantages and risks of taking part?

We do not anticipate any severe disadvantages or risks from taking part in our study. During the research, you may find some questions about yourself thought provoking, or they might lead you to reflect about yourself. You might also become aware of negative emotional experiences or tinnitus symptoms affecting your wellbeing. If that happens for you, there are relevant support services for you to reach out to for additional support. The contact details of these services will be provided at the end of this information sheet, the pre- and post-intervention questionnaire packs, as well as a debrief sheet provided at the end of the study. Although the risk of a data breach is very low, the University has strict data protection policies and procedures in place to ensure that all data are securely stored and handled in accordance with GDPR regulations.

7. What are the possible benefits of taking part?

We hope that all participants will experience some relief and positive change in their tinnitus through the guided meditation, either during or after the study. After completing the study, you will be entered into a lottery with the chance to win one of three £100 prizes. Your participation may also satisfy any curiosity about brief and novel interventions for tinnitus, while making meaningful contribution to the development of new psychological treatments to support those affected by tinnitus.

8. What if something goes wrong?

Please contact Jennifer McGowan on Jennifer.a.l.mcgowan@ucl.ac.uk should they wish to raise a complaint. Should they feel that your complaint has not been handled to your satisfaction, you can contact the Chair of the UCL Research Ethics Committee – ethics@ucl.ac.uk

9. Will my taking part in this project be kept confidential?

All the information that we collect about you during the course of the research will be kept strictly confidential. To protect your identity, we will assign you a unique participant ID which will be linked to your data in place of your name throughout the study. You will not be able to be identified in any ensuing reports or publications.

10. What will happen to the results of the research project?

Results of this study may be used as part of a coursework project by UCL students. They may also be published in an academic paper. You will not be identified in any report or publication. If you opt in to receiving the results of this study, they will be made available to you.

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