Social Isolation or LonelinessCUB-HS2025NCT06899308
Health Surveillance at Constructor University Bremen (CUB)
An observational study of Social Isolation or Loneliness and Anxiety, run by Jacobs University Bremen gGmbH at 2 sites in Germany.
Trial summary
The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation or Loneliness, Anxiety, Anxiety Depression (Mild or Not Persistent)
- What is being tested?
- questionnaire
- How many people
- 373 participants
- Where
- 2 sitesGermany
- Study dates
- 17 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This project contains three phases, the first one is quantitative phase (2025), the second one is qualitative phase (Dec 2025-April 2026) and the third one is again quantitative phase (2026). All Constructor University students and students Germany-wide who wish to take part in the study will be included. In the quantitative phase, Iinclusion criteria are english English or German language for reading and writing skills, internet access and student status. In the qualitative phase, the inclusion criteria are English or Chinese language and between 18-30 years old. Before the start of the survey period and directly before the start of the online survey or interview, all participants will receive all relevant study information and actively declare their consent to participate in the study.
Who may be able to join
- English language skills
- Reading and writing skills
- Internet access
- Student status
- Consent to participate in the study
Who cannot join
- Illiteracy
- Massively limited cognitive abilities ( i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in) and severe psychiatric disorders (e.g., severe depression)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Constructor University (formerly known as Jacobs University)
Bremen, Free Hanseatic City of Bremen, 28759
Constructor University Bremen
Bremen, Free Hanseatic City of Bremen, 28759
About this study
Official title: Health Surveillance by Constructor University Bremen (CUB) to Assess Germany-wide Students' Health and Wellbeing - Explanatory Sequential Mixed-Methods Approach
The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.
Read the detailed description
The aim of Health Surveillance, plus the additional research by means of qualitative interviews is to analyze and describe the state of stress and health of students at Constructor University (CU) by using a mixed-methods approach, as well as explore the association and mechanism between stress and health of students at CU (and employees at HAW Hamburg), key influencing factors and individual resources. In areas where there is a need for action, the Health Surveillance plus this project, the additional qualitative interviews can provide detailed insights and/or in-depth analyses. The Health Surveillance thus provides information on health-related topics and delivers scientifically sound information as a basis for health-promoting discussions in the subsequent follow-up process at various levels (e.g. faculties and departments). In addition, the Health Surveillance plus the additional interviews at CU contributes to comparability with surveys at other German universities through the use of validated and standardized measuring instruments and in-depth qualitative interviews with qualitative content analysis, as well as to add new constructs (i.e., artificial intelligence and digital technology use) as well as democratic competences, as this turned out to be new and important factors. Main hypotheses are
- The Health Surveillance gives insights into the state of stress and health of students at CU, key influencing factors and individual resources by using a mixed-methods approach.
- With the Health Surveillance, health promotion at CU by using a mixed-methods approach, as well as explore the association and mechanism between stress and health of students at CU (and employees at HAW Hamburg), can be guided, and the promotion of mental health (including the reduction of loneliness and discrimination) can be strengthened.
- The health of students (and employees at HAW Hamburg), their perceived stress, loneliness and discrimination/minorization (disadvantage) as well as substance use, interrelates with participation in health-promoting activities?
- Recommendations can be derived for qualification and skills training of multipliers for health-promoting behavior (e.g., J-peers)?
- Conditions
- Social Isolation or Loneliness, Anxiety, Anxiety Depression (Mild or Not Persistent), Health Behavior, Observational Study, Stress, Psychological
- Being tested
- questionnaire
- Keywords
- Healthy students, Health literacy, Disability, Age, Gender, Study characteristics, PHQ-4, Self-efficacy, Satisfaction with Life Scale (SWLS), Subjective health status, Student satisfaction, UCLA-LS, HEI-Stress, Mixed Method
- Medical subject headings
- Social Isolation, Anxiety Disorders, Lymphoma, Follicular, Health Behavior, Stress, Psychological, Substance-Related Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called assessments, introspection
Questionnaires and interviews were primarily used as assessment and introspection tools to collect data on study participants' experiences, perceptions, and behaviors. Their purpose was to facilitate measurement and reflection rather than to deliver an intervention. However, it is acknowledged that participation in questionnaires and interviews may have had unintended interventional effects. Specifically, the process of answering questions and reflecting on personal experiences can increase participants' self-awareness, prompt critical reflection, and potentially influence subsequent attitudes or behaviors.
| Study group | Role | What they receive |
|---|---|---|
| students in a community case study | Students at Constructor University Bremen being assessed by means of an online questionnaire in 2025 Receives: Other: questionnaire | |
| students in Germany | Students at germany wide being assessed by means of an online questionnaire or qualitative interviews in 2026 Receives: Other: questionnaire | |
| employees | Employees at HAW Hamburg wide being assessed by means of an online questionnaire in 2025 Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
University of California Los Angelese Loneliness Scale (UCLA-LS) - 3 Items (Schobin, Arriagada \& Gibson-Kunze, 2024), Range 1 (never/nie) - 5 (very often/sehr oft), higher scores mean a worse outcome
Loneliness in private and study context - 9 Items (Techniker Krankenkasse, 2024), Range 1 (often) - 4 (never), higher scores mean better outcomes
Measured: 2025 and 2026 (no matching)
Health literacy
Health literacy - 10 Items (Lenartz, Söllner \& Rudinger, 2014), Range 1 (does not apply/trifft überhaupt nicht zu) - 4 (does fully apply/trifft genau zu), higher scores mean a better outcome
Measured: 2025 and 2026 (no matching)
Secondary outcomes (4)
Depression and anxiety
Patient Health Questionnaire (PHQ-4) - 4 Items (Kroenke, Spitzer, Williams \& Löwe, 2009), Range 0 (not at all/überhaupt nicht) - 3 (nearly every day/beinahe jeden Tag), higher scores mean worse outcome
Measured: 2025 and 2026 (no matching)
Subjective health status
Subjective health status- 1 Item (WHO, 1996); Range 1 (very good/sehr gut) - 5 (very poor/schlecht), higher score means worse outcome
Measured: 2025 and 2026 (no matching)
Student satisfaction
Student satisfaction - 1 Item (Westermann, Heise, Spies \& Trautwein, 1996), Range 0 (not at all satisfied/gar nicht zufrieden) - 100 (completely satisfied/vollkommen zufrieden), higher scores mean better outcome
Measured: 2025 and 2026 (no matching)
HEI-Stress
Higher Education Institution Stress (HEI-Stress) - 3 Items (Schmidt, Sieverding, Scheiter \& Obergfell, 2013), Range 0 (not at all stressed/gar nicht gestresst) - 100 (very stressed/sehr gestresst), higher scores mean worse outcome
Measured: 2025 and 2026 (no matching)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start17 Mar 2025
- Primary completion30 Aug 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Isolation or LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobs University Bremen gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Hamburg University of Applied Sciences
- Responsible party
- Principal investigator, Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
- Investigators
- Sonia Lippke, PhD, Principal investigator, Constructor University Bremen gGmbH & Bremen International Graduate School of Social Sciences, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899308
- Sponsor's protocol ID
- CUB2025-03-12
- Acronym
- CUB-HS2025
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to data security
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Surveillance by Constructor University Bremen (CUB) to Assess Germany-wide Students' Health and Wellbeing - Explanatory Sequential Mixed-Methods Approach
- ClinicalTrials.gov ID
- NCT06899308
- Acronym / sponsor ID
- CUB-HS2025 / CUB2025-03-12
- Conditions
- Social Isolation or Loneliness, Anxiety, Anxiety Depression (Mild or Not Persistent), Health Behavior, Observational Study, Stress, Psychological
- Keywords
- Healthy students, Health literacy, Disability, Age, Gender, Study characteristics, PHQ-4, Self-efficacy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Jacobs University Bremen gGmbHUniversity, hospital or other
- Collaborators
- Hamburg University of Applied Sciences
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.
Detailed description
The aim of Health Surveillance, plus the additional research by means of qualitative interviews is to analyze and describe the state of stress and health of students at Constructor University (CU) by using a mixed-methods approach, as well as explore the association and mechanism between stress and health of students at CU (and employees at HAW Hamburg), key influencing factors and individual resources. In areas where there is a need for action, the Health Surveillance plus this project, the additional qualitative interviews can provide detailed insights and/or in-depth analyses. The Health Surveillance thus provides information on health-related topics and delivers scientifically sound information as a basis for health-promoting discussions in the subsequent follow-up process at various levels (e.g. faculties and departments). In addition, the Health Surveillance plus the additional interviews at CU contributes to comparability with surveys at other German universities through the use of validated and standardized measuring instruments and in-depth qualitative interviews with qualitative content analysis, as well as to add new constructs (i.e., artificial intelligence and digital technology use) as well as democratic competences, as this turned out to be new and important factors. Main hypotheses are
- The Health Surveillance gives insights into the state of stress and health of students at CU, key influencing factors and individual resources by using a mixed-methods approach.
- With the Health Surveillance, health promotion at CU by using a mixed-methods approach, as well as explore the association and mechanism between stress and health of students at CU (and employees at HAW Hamburg), can be guided, and the promotion of mental health (including the reduction of loneliness and discrimination) can be strengthened.
- The health of students (and employees at HAW Hamburg), their perceived stress, loneliness and discrimination/minorization (disadvantage) as well as substance use, interrelates with participation in health-promoting activities?
- Recommendations can be derived for qualification and skills training of multipliers for health-promoting behavior (e.g., J-peers)?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| students in a community case study | – | Other: questionnaireStudents at Constructor University Bremen being assessed by means of an online questionnaire in 2025 |
| students in Germany | – | Other: questionnaireStudents at germany wide being assessed by means of an online questionnaire or qualitative interviews in 2026 |
| employees | – | Other: questionnaireEmployees at HAW Hamburg wide being assessed by means of an online questionnaire in 2025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This project contains three phases, the first one is quantitative phase (2025), the second one is qualitative phase (Dec 2025-April 2026) and the third one is again quantitative phase (2026). All Constructor University students and students Germany-wide who wish to take part in the study will be included. In the quantitative phase, Iinclusion criteria are english English or German language for reading and writing skills, internet access and student status. In the qualitative phase, the inclusion criteria are English or Chinese language and between 18-30 years old. Before the start of the survey period and directly before the start of the online survey or interview, all participants will receive all relevant study information and actively declare their consent to participate in the study.
Key inclusion criteria (5 listed)
- English language skills
- Reading and writing skills
- Internet access
- Student status
- Consent to participate in the study
Key exclusion criteria (2 listed)
- Illiteracy
- Massively limited cognitive abilities ( i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in) and severe psychiatric disorders (e.g., severe depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAlso: assessments, introspectionQuestionnaires and interviews were primarily used as assessment and introspection tools to collect data on study participants' experiences, perceptions, and behaviors. Their purpose was to facilitate measurement and reflection rather than to deliver an intervention. However, it is acknowledged that participation in questionnaires and interviews may have had unintended interventional effects. Specifically, the process of answering questions and reflecting on personal experiences can increase participants' self-awareness, prompt critical reflection, and potentially influence subsequent attitudes or behaviors. | Other | employees, students in Germany, students in a community case study |
Primary outcome
Loneliness
Time frame: 2025 and 2026 (no matching)
University of California Los Angelese Loneliness Scale (UCLA-LS) - 3 Items (Schobin, Arriagada \& Gibson-Kunze, 2024), Range 1 (never/nie) - 5 (very often/sehr oft), higher scores mean a worse outcome Loneliness in private and study context - 9 Items (Techniker Krankenkasse, 2024), Range 1 (often) - 4 (never), higher scores mean better outcomes
Health literacy
Time frame: 2025 and 2026 (no matching)
Health literacy - 10 Items (Lenartz, Söllner \& Rudinger, 2014), Range 1 (does not apply/trifft überhaupt nicht zu) - 4 (does fully apply/trifft genau zu), higher scores mean a better outcome
4 secondary outcomes
Depression and anxiety
Time frame: 2025 and 2026 (no matching)
Subjective health status
Time frame: 2025 and 2026 (no matching)
Student satisfaction
Time frame: 2025 and 2026 (no matching)
HEI-Stress
Time frame: 2025 and 2026 (no matching)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- World Health Organization (WHO) (Hrsg.). (2996). Health interview survey: Towards international harmonization of methods and instruments. World Health Organization, Regional Office for Europe, Kopenhagen.Link provided by the sponsor.
- Burian, J., Lehnchen, J. Deptolla, Z., Heinrichs, K., Stock, C. (2023). Abschlussbericht zum Vorhaben "Studienbedingungen und (psychische) Gesundheit Studierender: Weiterentwicklung und Erprobung des Bielefelder Fragebogens zu StudienbedingungenLink provided by the sponsor.
- Kroenke, K., Spitzer, R. L., Williams, J. B. W., \& Löwe, B. (2009). An Ultra-Brief Screening Scale for Anxiety and Depression: The PHQ-4. Psychosomatics, 50(6), 613-621. DOI:Link provided by the sponsor.
- Schobin, J, Arriagada, C., Gibson-Kunze, M. (2024). Einsamkeitsbarometer 2024. Langzeitentwicklund von Einsamkeit in Deutschland. Einsamkeitsbarometer 2024, 1, 1-78. Bundesministerium für Familie, Senioren, Frauen und Jugend (BMFSFJ) (Hrsg.).Link provided by the sponsor.
- Techniker Krankenkasse. (2024). Einsamkeitsreport 2024. Techniker Krankenkasse: Hamburg (Hrsg.).Link provided by the sponsor.
- SOEP-IS Group (2022). SOEP-IS 2020 - Fragebogen für die SOEP-Innovations-Stichprobe. SOEP Survey Papers 1143: Series A - Survey Instruments (Erhebungsinstrumente). Berlin: DIW Berlin/SOEP.Link provided by the sponsor.
- Individual participant dataSharing planned: No. due to data security
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Lippke, PhD principal investigator
Constructor University Bremen gGmbH & Bremen International Graduate School of Social Sciences, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Isolation or Loneliness and Anxiety, run by Jacobs University Bremen gGmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: 2025 and 2026 (no matching)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.