LonelinessGemsENCT07581171
Creating Encounters Between Generations - Together Instead of Alone (GemsE)
A study testing Mechanisms and effectiveness of intergenerational tandems in people with Loneliness and Mental Well-being, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Loneliness, Mental Well-being, Health-related Quality of Life
- What is being tested?
- Mechanisms and effectiveness of intergenerational tandems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2026to 1 Dec 2026
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older adults aged 60 years and older who are residents of Hamburg
- Children and adolescents aged 12 to 21 years with at least one parent with a mental illness and who are residents of Hamburg
- Sufficient German language proficiency
- Ability and willingness to provide informed consent to participate in the study
Who cannot join
- Children and adolescents with severe acute psychological symptoms requiring inpatient treatment, including acute suicidality, acute substance use, or acute psychotic symptoms
- Older adults with acute psychological crises or untreated severe mental illness preventing reliable participation
- Older adults with cognitive impairment or dementia preventing reliable participation in the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Silke Wiegand-Grefe, Prof. Dr., +4940741053603, swiegand-grefe@uke.de
Jana Wiehe, 49040741024155, j.wiehe@uke.de
About this study
Official title: Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and quality of life of both groups. The aim of the study is to scientifically record the effect of these sponsorships and to find out how such encounters can be successfully organized.
Read the detailed description
The GemsE project - Creating Encounters: Generations in Action - Together Instead of Alone is an interventional study evaluating intergenerational mentoring between seniors and CYP from families with parents who have mental illness. The aim is to build stable, voluntary relationships that reduce loneliness and improve the mental well-being and health-related quality of life of both groups.
As part of the study, approximately 40 seniors and 40 children or adolescents will be accompanied in sponsorships over a period of six months. The impact of the sponsorships will be measured using standardized, validated questionnaires on loneliness, psychosocial well-being, and health-related quality of life. The results should provide insights into how intergenerational sponsorships can be effectively designed and integrated into psychosocial care services.
- Being tested
- Mechanisms and effectiveness of intergenerational tandems
- Keywords
- elderly people, children of parents with mental illness, loneliness, psychosocial health, intergenerational tandems
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanisms and effectiveness of intergenerational tandemsBehavioural
The project Creating Encounters Between Generations - Together Instead of Alone (German acronym GemsE) aims to provide social support and integration for both groups by establishing tandems between lonely senior citizens and COPMI, and to scientifically evaluate the effectiveness of these tandems. The tandems run for six months, with weekly meetings between senior and CYP. The tandems consist of weekly individual meetings with joint activities such as playing games, learning, cooking, or going for walks. Senior citizens and CYP engage in tandems built on trust, shared experiences, and cooperation, fostering connections that benefit both sides at eye level. Project coordinators accompany the participants and support the process management.
| Study group | Role | What they receive |
|---|---|---|
| Establishing intergenerational tandems | Experimental | The intervention focuses on establishing stable mentoring relationships between senior citizens and children or adolescents from families with parents who have mental health issues.
The main objectives of this intervention are to build reliable relationships, reduce loneliness, and promote mental well-being and quality of life for both groups.
This intervention is coordinated by the project team at GemsE - Creating encounters: Generations in Action - Together Instead of Alone -. Receives: Behavioral: Mechanisms and effectiveness of intergenerational tandems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
The primary clinically relevant parameter of the study is the experience of loneliness among children, adolescents, and seniors, measured using the 6-item short version of the De Jong Gierveld Loneliness Scale.The response options are three-point (yes, more or less, no) from 0-6 with higher scores indicating greater loneliness.
Measured: Change from baseline to 6 months.
Secondary outcomes (5)
Mental well-being
The mental well-being of seniors and young adults is assessed using the SDQ 18+, while the SDQ 11-17 is used for self-assessment for adolescents. Scores range from 0 to 40, with higher scores indicating greater psychological difficulties and poorer mental well-being.
Measured: Change from baseline to 6 months.
Health-Related Quality of Life in Adults
Health-related quality of life in participants aged 18 years and older will be assessed using the SF-12. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Change from baseline to 6 months.
Health-Related Quality of Life in Children and Adolescents
Health-related quality of life in participants aged 12 to 17 years will be assessed using the KIDSCREEN-27 Questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Change from baseline to 6 months.
Health-Related Quality of Life in Adults (EQ-5D-5L)
Health-related quality of life in participants aged 18 years and older will be assessed using the EQ-5D-5L. The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
Measured: Change from baseline to 6 months
Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Health-related quality of life in participants from 12-17 years will be assessed using the EQ-5D-Y-5L. The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Silke Wiegand-Grefe, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581171
- Sponsor's protocol ID
- 2025-101662-BO-ff
- Other IDs
- 2025
- Acronym
- GemsE
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
- ClinicalTrials.gov ID
- NCT07581171
- Acronym / sponsor ID
- GemsE / 2025-101662-BO-ff
- Keywords
- elderly people, children of parents with mental illness, loneliness, psychosocial health, intergenerational tandems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 May 2026 (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.
Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and quality of life of both groups. The aim of the study is to scientifically record the effect of these sponsorships and to find out how such encounters can be successfully organized.
Detailed description
The GemsE project - Creating Encounters: Generations in Action - Together Instead of Alone is an interventional study evaluating intergenerational mentoring between seniors and CYP from families with parents who have mental illness. The aim is to build stable, voluntary relationships that reduce loneliness and improve the mental well-being and health-related quality of life of both groups.
As part of the study, approximately 40 seniors and 40 children or adolescents will be accompanied in sponsorships over a period of six months. The impact of the sponsorships will be measured using standardized, validated questionnaires on loneliness, psychosocial well-being, and health-related quality of life. The results should provide insights into how intergenerational sponsorships can be effectively designed and integrated into psychosocial care services.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Establishing intergenerational tandems | Experimental | Behavioral: Mechanisms and effectiveness of intergenerational tandemsThe intervention focuses on establishing stable mentoring relationships between senior citizens and children or adolescents from families with parents who have mental health issues. The main objectives of this intervention are to build reliable relationships, reduce loneliness, and promote mental well-being and quality of life for both groups. This intervention is coordinated by the project team at GemsE - Creating encounters: Generations in Action - Together Instead of Alone -. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Older adults aged 60 years and older who are residents of Hamburg
- Children and adolescents aged 12 to 21 years with at least one parent with a mental illness and who are residents of Hamburg
- Sufficient German language proficiency
- Ability and willingness to provide informed consent to participate in the study
Key exclusion criteria (3 listed)
- Children and adolescents with severe acute psychological symptoms requiring inpatient treatment, including acute suicidality, acute substance use, or acute psychotic symptoms
- Older adults with acute psychological crises or untreated severe mental illness preventing reliable participation
- Older adults with cognitive impairment or dementia preventing reliable participation in the intervention
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 |
|---|---|---|
| Mechanisms and effectiveness of intergenerational tandemsThe project Creating Encounters Between Generations - Together Instead of Alone (German acronym GemsE) aims to provide social support and integration for both groups by establishing tandems between lonely senior citizens and COPMI, and to scientifically evaluate the effectiveness of these tandems. The tandems run for six months, with weekly meetings between senior and CYP. The tandems consist of weekly individual meetings with joint activities such as playing games, learning, cooking, or going for walks. Senior citizens and CYP engage in tandems built on trust, shared experiences, and cooperation, fostering connections that benefit both sides at eye level. Project coordinators accompany the participants and support the process management. | Behavioural | Establishing intergenerational tandems |
Primary outcome
Loneliness
Time frame: Change from baseline to 6 months.
The primary clinically relevant parameter of the study is the experience of loneliness among children, adolescents, and seniors, measured using the 6-item short version of the De Jong Gierveld Loneliness Scale.The response options are three-point (yes, more or less, no) from 0-6 with higher scores indicating greater loneliness.
5 secondary outcomes
Mental well-being
Time frame: Change from baseline to 6 months.
Health-Related Quality of Life in Adults
Time frame: Change from baseline to 6 months.
Health-Related Quality of Life in Children and Adolescents
Time frame: Change from baseline to 6 months.
Health-Related Quality of Life in Adults (EQ-5D-5L)
Time frame: Change from baseline to 6 months
Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Time frame: Change from baseline to 6 months
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Silke Wiegand-Grefe, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanisms and effectiveness of intergenerational tandems in people with Loneliness and Mental Well-being, run by Universitätsklinikum Hamburg-Eppendorf at 1 site 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Silke Wiegand-Grefe, Prof. Dr. (+4940741053603, swiegand-grefe@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: Change from baseline to 6 months.). 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 10 Aug 2026.