General Information on the Study and Participants [Version 5]

Title of the study: The influence of established and subjectively perceived and assessed individual characteristics on the healthcare utilisation behaviour of people with depressive disorders? A longitudinal study to supplement the ‘Behavioural Model of Health Services Use’ and to examine needs-based service utilisation

A warm welcome to our study ‘The influence of established and subjectively perceived and evaluated individual characteristics on the service-use behaviour of people with depressive disorders? A longitudinal study to supplement the ‘Behavioural Model of Health Services Use’ and to examine needs-congruent service use. To ensure we can provide you with accurate information about our study, we would be grateful if you could take the time to read the following pages.

Data collection is now complete! We would like to extend our heartfelt thanks to all study participants for their support!

Purpose(s) of the study
Around 20 out of every 100 people suffer from depression at some point in their lives. Only about one in three people suffering from depression seeks help from the healthcare system for these problems. To improve healthcare provision, it is important to investigate the reasons why people do not seek help.

The first survey was completed at the end of November 2020, with 925 people from across Germany taking part. The second round of the survey will begin in April 2021. All participants in the first survey will be contacted again by telephone and interviewed by the social and opinion research institute USUMA GmbH approximately 12 months after their initial interview. In addition, up to 32 people will be interviewed in more detail in person by staff from the University of Oldenburg. This study is for academic research purposes.

study procedure As the study consists exclusively of interviews, there are no medical risks associated with taking part. The interviews focus on mental health complaints.

Your participation in this study will not result in any health benefits for you. However, the results of this study may help to improve the care provided to people with mental health complaints.

We have commissioned USUMA GmbH to conduct the two telephone interviews. Your telephone number was selected at random using the ADM telephone sampling system (www.adm-ev.de/leistungen/arbeitsgemeinschaft-adm-stichproben/). To process your data during the two telephone interviews and to contact you, we have entered into a so-called data processing agreement with USUMA GmbH in accordance with Article 28 of the GDPR. This means that USUMA GmbH processes your personal data P.p. and must also comply with the strict data protection provisions of the GDPR. At the start of the first telephone interview, we asked you nine questions to determine whether you fell within the group being studied. If this was the case, this was followed by a more detailed questionnaire focusing on mental health complaints and the use of healthcare services. Following the completion of the first wave of the survey, USUMA GmbH donated a total of €1,000 to the Foundation for Mental Health. This foundation is particularly committed to projects designed to combat the stigmatisation of people with mental health issues. By taking part, you are therefore not only contributing to scientific knowledge but also supporting the projects of the Foundation for Mental Health.

If you provided your postal address or email address at the end of the first telephone interview, we will send you response lists (lists of complaints and symptoms) by post or email shortly before the second telephone interview takes place; you may need these to answer certain questions during the second telephone interview. Please keep these lists safely near your telephone until the second call from the staff at USUMA GmbH. If you receive the lists digitally by email, it would be helpful if you could either print them out or save them in such a way that you can access them during the second telephone interview. The second interview will last approximately 45 minutes and will take place about one year after the first telephone interview. You will also receive further details in the letter or email regarding the planned face-to-face interviews, which are to be held with up to 32 people. This information is also available for download on this page (file:‘EIN-IMDE written study information – face-to-face interview’).

The telephone interviews will not be recorded. Only the answers you provide to the questions asked will be noted down. Following the second telephone interview, up to 32 people will be selected for more in-depth interviews. Provided you give your consent at the end of the second telephone interview, the selected participants will be contacted by staff at the University of Oldenburg to arrange dates for face-to-face interviews. If the COVID-19 situation permits, there is the option of conducting the interview with you at the University of Oldenburg. In that case, there will be a hygiene protocol adapted to the current situation, which both you, as the respondent, and we, as the interviewers, must adhere to. Should a face-to-face interview not be possible or if you do not wish to have one, we will conduct the interviews via video call or telephone. You will receive an expense allowance in all cases. If you decide to travel to the University of Oldenburg, you will be insured for the journey there and back and whilst on site, and your travel expenses will be reimbursed. Before the face-to-face interview begins, we will brief you again and obtain your written consent. If you are interested, you are welcome to read further information about this potential third interview in the written programme information (file:‘EIN-IMDE written programme information – face-to-face interview’).

Categories of personal data being processed

As part of this study, depending on your classification based on a so-called PHQ-9 score [1], various items of your personal data will be collected. This score was already determined during the first telephone call with you. In all cases – at least initially – your telephone number and your Federal State, as well as your age, gender and health data based on the so-called PHQ-9 test, will be recorded.

If you are one of the 925 people who exceeded a certain threshold (PHQ-9 score ≥ 5) at the start of the first survey, we will ask you further questions during the two interviews using scientifically established questionnaires[2] . In these questionnaires, you will essentially provide further health data relating to your mental health complaints and your use of healthcare services. You can find out exactly which data is collected and processed in this context either in advance or during the survey by referring to the respective questionnaires. You are not obliged to answer every question and may stop the interview at any time. Furthermore, we will process your contact details (name, address, telephone number) so that we may contact you at a later date, provided you consent to this. We will only process your payment details (name, address, date, amount paid, purpose of payment, bank details) if you take part in one of the maximum of 32 face-to-face interviews.

Voluntary participation and anonymity
Participation is voluntary. It will only take place with your consent given over the telephone. You may withdraw from this study at any time and without giving a reason, without suffering any disadvantage as a result. The data and personal information collected as part of this study, as described above, will be treated confidentially. The confidentiality of your data is guaranteed at all times, and all persons involved have signed a confidentiality agreement. Furthermore, the results of the study will only be published in anonymised form. This means that the data can no longer be traced back to a specific individual.

Duration of the study
The study will last approximately 1.5 years. The telephone interviews will last up to 60 minutes, although the first telephone interview will be shorter. The third face-to-face interview in Oldenburg, or via video call or telephone, will take approximately 45 minutes.

Data processing procedure
In order to be able to link the information you provide in the second telephone interview to that provided in the first telephone interview, we will generate a multi-character combination of letters or numbers, also known as a code. On a separate coding list, which is stored on data storage media belonging to USUMA GmbH, the code will be assigned to your telephone number. Only employees of USUMA GmbH have access to the key that enables the survey data to be personally linked to your telephone number. This list is not stored together with the interview data. This enables USUMA GmbH to contact you for the second telephone interview, and allows us, the research group at the University of Oldenburg, to match your details from the second interview with those from the first telephone interview using the code.

At the end of the second telephone interview, you may also give your separate consent for USUMA GmbH to pass on your code and your contact details to Dr Brütt and her staff. This will enable Dr Brütt and her colleagues to identify participants for in-depth interviews based on their analyses and to contact you. In this case, the data will be anonymised following the third, face-to-face interview. Further information on this can be found in the written study information sheet (file:‘EIN-IMDE Study Information – Face-to-Face Interviews’).

If you do not give your consent to take part in a face-to-face interview, the data collected will be forwarded in anonymised form to the study group at the University of Oldenburg once the second telephone interview has been completed. This is done electronically in encrypted form. At the University of Oldenburg, the data will be analysed by Dr Brütt and her colleagues in accordance with the study’s research questions.

You may withdraw your consent at any time without giving a reason. Until the data has been anonymised, you may decide whether data already collected from you should be deleted or may be reused in anonymised form. Once the data has been anonymised, it is no longer possible to link it to any individual and, consequently, individual data records can no longer be deleted.

Once data collection has been completed (second telephone interview or face-to-face interview), the coding list will be deleted and any further analysis will be carried out anonymously. The anonymised data will be stored at the University of Oldenburg, Ammerländer Heerstraße 140, 26129 Oldenburg for 10 years and then permanently deleted.

Once the first telephone interview has been completed, USUMA GmbH will forward your address details, in pseudonymised form, to Dr Brütt and her colleagues. At this stage, they will not be able to link your health data to you personally. Only contact details, including your address and name, will be transmitted (without pseudonymisation codes). Once this interim process has been completed (receipt of the response lists and written information regarding the personal qualitative interviews), the project staff will delete your address details.

Once the second telephone interview has been completed and the full set of personal data has been forwarded to Dr Brütt and her team for analysis, USUMA GmbH will delete the coding list. At that point, USUMA GmbH will no longer be able to link your data to you personally.

If you receive an expense allowance, your payment details will be processed by Division 2 for accounting purposes. For this reason, Division 2: Finances at the University of Oldenburg is authorised to access your payroll data. Your payroll data must be retained by Division 2 for at least 10 years in accordance with Section 147 of the German Fiscal Code.

Use of data
This study is for research purposes only. Your data will not be passed on to third parties.

Data protection
Contact details of the data controllers and their data protection officers