LonelinessNCT06495801
Effectiveness of a Mobile Application in Improving Employees' Social Well-being.
A study testing Frendie PRO mobile application in people with Loneliness and Social Isolation, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are: Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Social Isolation, Social Support
- What is being tested?
- Frendie PRO mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteFinland
- Study dates
- 20 Sep 2024to 1 Aug 2025
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All employees working at the company/team/department participating in the study and starting to use the Frendie PRO mobile application within the study period.
- Ability to fill the questionnaires online in Finnish
Who cannot join
- incapable of using questionnaire online
- does not know Finnish well enough to answer the questions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Työntekijöiden Sosiaalisen Hyvinvoinnin lisääminen Mobiilisovelluksen Avulla (Effectiveness of a Mobile Application in Improving Employees' Social Well-being)
The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are:
Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees?
Read more
Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms).
Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.
Read the detailed description
Participants will be recruited from workplaces that use the Frendie PRO mobile application. After collecting baseline data, each workplace will be randomly assigned to treatment or control conditions. The unit of randomization is a workplace (or a team or department in bigger organizations).
The intervention group will be encouraged to download and start using the Frendie PRO mobile application. The control group will be informed of the date when they will have access to it (six months after the baseline).
Both groups are asked to participate in two follow-ups - a 3-month follow-up and a 6-month follow-up.
- Conditions
- Loneliness, Social Isolation, Social Support, Depressive Symptoms
- Being tested
- Frendie PRO mobile application
- Keywords
- loneliness, work well-being, social well-being
- Medical subject headings
- Social Isolation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frendie PRO mobile applicationBehavioural
Frendie PRO mobile application offers employees an environment to manage their social relationships, organize leisure activities, and discuss personal or work-related matters.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Frendie PRO mobile application |
| Wait-list controls | No intervention | The group will have access to the mobile application after the six-month follow-up period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
University of California, Los Angeles (UCLA) Loneliness Scale
Measured: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Social Isolation
The Social Isolation scale was modified from an index used by Christiansen et al. (2021). Christiansen and colleagues, in turn, created it inspired by the detailed Social Network Index created by Berkman and Syme (1979).
Communication frequency with the following groups is measured:
- family members who live elsewhere
- friends
- colleagues or fellow students at the workplace/school and outside of the workplace/school
- neighbors and local community
- people from social clubs, hobby groups, and religious organisations at and outside the meetings.
Measured: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Secondary outcomes (3)
Social support
Oslo Social Support Scale
Measured: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Depressive symptoms
Patient Health Questionnaire-9 (PHQ9)
Measured: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Workplace loneliness
Specific scale regarding loneliness experienced at workplaces. Includes 5 items that are modified from the UCLA loneliness scale. It was validated in Finnish adult population. Please see Kemppinen and Tanskanen (2023) for full description:
Kemppinen, S., Tanskanen, J., 2023. Suomenkielisen työyksinäisyysmittarin validointi etä- ja hybridityöläisillä (Eng title: Validation of Finnish loneliness at work scale with remote and hybrid worker sample). Psykologia 58, 198-219.
Measured: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start20 Sep 2024
- Primary completion20 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants of the intervention group are given access and encouraged to use Frendie PRO mobile application
- Masking
- None (open label)
- Enrolment
- 1,012 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Work Environment Fund
- Responsible party
- Principal investigator, Siiri-Liisi Kraav, University of Eastern Finland
- Investigators
- Siiri-Liisi Kraav, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495801
- Sponsor's protocol ID
- 240128
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After 10 years, anonymized data will be offered to the Finnish Social Science Data Archive. If the data will not be accepted there, it will be destroyed.
Publications
Kraav SL, Schoenmakers E, Linnosmaa I, Sorola S, Tolmunen T. Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation. Contemp Clin Trials. 2025 Oct;157:108060. doi: 10.1016/j.cct.2025.108060. Epub 2025 Aug 28.
PubMed 40885488
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Työntekijöiden Sosiaalisen Hyvinvoinnin lisääminen Mobiilisovelluksen Avulla (Effectiveness of a Mobile Application in Improving Employees' Social Well-being)
- ClinicalTrials.gov ID
- NCT06495801
- Acronym / sponsor ID
- 240128
- Conditions
- Loneliness, Social Isolation, Social Support, Depressive Symptoms
- Keywords
- loneliness, work well-being, social well-being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,012 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Finnish Work Environment Fund
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Jul 2024 (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 goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are:
Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees?
Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms).
Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.
Detailed description
Participants will be recruited from workplaces that use the Frendie PRO mobile application. After collecting baseline data, each workplace will be randomly assigned to treatment or control conditions. The unit of randomization is a workplace (or a team or department in bigger organizations).
The intervention group will be encouraged to download and start using the Frendie PRO mobile application. The control group will be informed of the date when they will have access to it (six months after the baseline).
Both groups are asked to participate in two follow-ups - a 3-month follow-up and a 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants of the intervention group are given access and encouraged to use Frendie PRO mobile application
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Frendie PRO mobile application |
| Wait-list controls | No intervention | –The group will have access to the mobile application after the six-month follow-up period. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All employees working at the company/team/department participating in the study and starting to use the Frendie PRO mobile application within the study period.
- Ability to fill the questionnaires online in Finnish
Key exclusion criteria (2 listed)
- incapable of using questionnaire online
- does not know Finnish well enough to answer the questions
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 |
|---|---|---|
| Frendie PRO mobile applicationFrendie PRO mobile application offers employees an environment to manage their social relationships, organize leisure activities, and discuss personal or work-related matters. | Behavioural | Intervention |
Primary outcome
Loneliness
Time frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
University of California, Los Angeles (UCLA) Loneliness Scale
Social Isolation
Time frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
The Social Isolation scale was modified from an index used by Christiansen et al. (2021). Christiansen and colleagues, in turn, created it inspired by the detailed Social Network Index created by Berkman and Syme (1979). Communication frequency with the following groups is measured: * family members who live elsewhere * friends * colleagues or fellow students at the workplace/school and outside of the workplace/school * neighbors and local community * people from social clubs, hobby groups, and religious organisations at and outside the meetings.
3 secondary outcomes
Social support
Time frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Depressive symptoms
Time frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
Workplace loneliness
Time frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
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 2 May 2025.
- Derived from this study: PubMed 40885488Kraav SL, Schoenmakers E, Linnosmaa I, Sorola S, Tolmunen T. Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation. Contemp Clin Trials. 2025 Oct;157:108060. doi: 10.1016/j.cct.2025.108060. Epub 2025 Aug 28.
- Individual participant dataSharing planned: Yes. After 10 years, anonymized data will be offered to the Finnish Social Science Data Archive. If the data will not be accepted there, it will be destroyed.
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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.
Siiri-Liisi Kraav, PhD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frendie PRO mobile application in people with Loneliness and Social Isolation, run by University of Eastern Finland at 1 site in Finland.
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 2 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 2 May 2025. 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 Finland. 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: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up). 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?
On the ClinicalTrials.gov record for NCT06495801, which also lists 1 linked publication.
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 2 May 2025.