LonelinessNCT06805136
Establishing Social Connections in Urban Areas: Evaluating a Community-based Programme
A study testing Community-based social interaction intervention in people with Loneliness, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
The aim of this study is to evaluate the feasibility and acceptability of a new community-based programme designed to tackle loneliness for young and working-age adults. The programme focuses on encouraging social interactions and connections through offering community initiatives and activities, online spaces for… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Loneliness
- What is being tested?
- Community-based social interaction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Feb 2025to 1 Jun 2028
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-40
- Reside in London
- Reports that they are some of the time or often lonely in response to a single questionnaire item ("How often do you feel lonely?)
- No prior interaction with the community-based intervention we are investigating
- Able to communicate in English sufficiently well to engage in qualitative interviews and complete the outcome measures and questionnaires.
- Available and willing to participate in the study for 18 weeks
Who cannot join
- Age < 20 or age >40.
- Resides outside of London.
- Does not report frequent levels of loneliness ("hardly ever or never" in response to single questionnaire item).
- Previously attended any event or is an existing member of the community-based programme that is forming the intervention arm.
- Unable to communicate even with communication support.
- Planned unavailability for >3 weeks during intervention and follow up periods.
- Participating in another research project related to loneliness.
- Reports current severe unstable health problems (mental or physical) or is deemed overburdened with respect to participating in research.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
In the community in London, England
London
David Gradon, 07590 420947, david@friendship-project.co.uk
- Not yet recruiting
Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of London
London
Jennifer Lau, 020 7882 3850, j.lau@qmul.ac.uk
Jennifer Lau
About this study
Official title: Tackling Youth Loneliness in Urban Areas: Measuring Feasibility, Acceptability, and Benefits of a Community-based Intervention.
The aim of this study is to evaluate the feasibility and acceptability of a new community-based programme designed to tackle loneliness for young and working-age adults. The programme focuses on encouraging social interactions and connections through offering community initiatives and activities, online spaces for interaction, and free or low-cost social events for young adults. Further aims of this study are to determine the cost-effectiveness of the programme.
Read the detailed description
Loneliness is associated with adverse mental and physical health outcomes. Most interventions are aimed at older adults even though young adults, including those of working-age, have been identified as being at-risk for persistent loneliness. This study aims to formatively evaluate the feasibility and acceptability of a community-based social interaction intervention. Therefore, the main objectives of this study are to:
- Assess the feasibility and acceptability of the community-based intervention.
- To determine the costs and effects related to the community-based intervention using quantitative feasibility study data and qualitative interviews with study participants.
In this mixed-methods two-arm randomised feasibility study with qualitative evaluation, participants will be randomly allocated to the community-based intervention over 12 weeks or to the wait-list control group. The intervention consists of weekly community social activities with the aim of reducing feelings of loneliness. Participants in the wait-list control group can continue any standard care or support they were receiving e.g. use of GP or mental health services. For both groups, online self-report assessments will take place at baseline (time 0, t0), 12-week follow-up (end of the intervention period; time 1, t1) and 6-weeks post intervention (18-weeks after baseline, time 2, t2). For the intervention group, an additional qualitative interview will be taken at the final timepoint (time 3, t3; 6 weeks post-intervention).
- Conditions
- Loneliness
- Being tested
- Community-based social interaction intervention
- Keywords
- Loneliness, Young adults, Social interaction, Community intervention, Urban, Feasibility, Acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based social interaction interventionBehavioural
The intervention focuses on free or low-cost social interaction by offering community initiatives and activities, online spaces for interaction, and social events to young and working-age adults in London. Activities include but are not limited to social walks, bingo nights, board game afternoons and pub quizzes.
| Study group | Role | What they receive |
|---|---|---|
| Community-based intervention group | Experimental | The participants in the community-based intervention group will be invited to attend weekly social activities over a period of 12 weeks. Participants must be committed to attend at least 8 activities during the 12 week period. Following the 12-week intervention period, the intervention group will enter a 6-week post-intervention period where they will no longer be encouraged to attend the activities to help understand the impact of stopping the intervention. Receives: Behavioral: Community-based social interaction intervention |
| Wait-list control | No intervention | The participants allocated to the wait-list control will continue to receive any standard care they were receiving (e.g., National Health Services (NHS) services) during the 18-week trial. All participants will be eligible and able to access the community-based intervention as independent members once the trial ends (after 18 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
To determine feasibility, we will record: (i) Number of participants that complete the screening stage. (ii) Number of eligible participants following the screening. (iii) Number of participants who consent to take part in the intervention. (iv) Number of participants randomised. (v) Number of participants who drop out and reasons offered for this. (vi) During the intervention: range and average number of sessions completed as a proportion of those offered. Data completeness for each questionnaire will be summarised at each time point.
Measured: From enrollment to 6-weeks post-intervention (18 weeks total)
Acceptability
Qualitative interviews will be conducted to explore participants' experiences of the intervention, barriers and facilitators, perceived active ingredients, potential benefits, and suggested changes. They will also seek to understand the reach, engagement, and benefits of the intervention by focusing on topics around engagement, tolerability, and safety. The interviews will be conducted with the intervention group and facilitated using topic guides.
Measured: 6-weeks post intervention
Secondary outcomes (6)
Loneliness
The University of California Los Angeles (UCLA) loneliness scale. The UCLA loneliness scale consists of 20 questions related to loneliness, including how often you 'lack companionship', 'feel left out', or 'feel isolated from others'. Higher scores indicate greater levels of loneliness
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Wellbeing
The short version of the Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS). The SWEMWBS measures mental wellbeing using 7 statements with a recall period of 2 weeks. Higher scores indicate higher positive mental wellbeing.
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Social connectedness
The Social Connectedness Scale (SCS). This SCS scale measures connectedness using 20 items measuring belongingness, on a 6-point Likert scale.
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Health Related Quality of Life
The European Quality of Life 5 Dimensions 5 Level version (EQ-5D-5L) has five dimensions, each dimension has five levels of response. The dimensions cover mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are used to obtain utility values where one is perfect health, 0 represents death, and negative scores reflect health states worse than death.
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Capability
ICEpop CAPability measure for Adults (ICECAP-A). This tool assesses five capabilities covering feeling settled/secure, love/friendship/support, being independent, achievement/progress, and enjoyment/pleasure. Each capability has four levels of response.
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Client Service Receipt Inventory
Client Service Receipt Inventory (CSRI) captures health and social care resource utilisation. These will be recorded over a 6-week period. Questions will include frequency of resource use in primary, community, and secondary care, medications, and employment status. Health and social care resource use will be used, combined unit costs, to evaluate the cost of healthcare resources used by each group (intervention and control) Unit costs will be obtained from the Unit Costs of Health and Social Care, supplemented with the National Reference Costs.
Measured: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start12 Feb 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805136
- Sponsor's protocol ID
- QME24. 0657
- Other IDs
- APP19330
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge.
Publications
Al-Janabi H, Flynn TN, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012 Feb;21(1):167-76. doi: 10.1007/s11136-011-9927-2. Epub 2011 May 20.
PubMed 21598064Shah N, Cader M, Andrews B, McCabe R, Stewart-Brown SL. Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): performance in a clinical sample in relation to PHQ-9 and GAD-7. Health Qual Life Outcomes. 2021 Nov 24;19(1):260. doi: 10.1186/s12955-021-01882-x.
PubMed 34819104Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.
PubMed 660402Bryan BT, Thompson KN, Goldman-Mellor S, Moffitt TE, Odgers CL, So SLS, Uddin Rahman M, Wertz J, Matthews T, Arseneault L. The socioeconomic consequences of loneliness: Evidence from a nationally representative longitudinal study of young adults. Soc Sci Med. 2024 Feb 22;345:116697. doi: 10.1016/j.socscimed.2024.116697. Online ahead of print.
PubMed 38490911Eager S, Johnson S, Pitman A, Uribe M, Qualter P, Pearce E. Young people's views on the acceptability and feasibility of loneliness interventions for their age group. BMC Psychiatry. 2024 Apr 23;24(1):308. doi: 10.1186/s12888-024-05751-x.
PubMed 38654301
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tackling Youth Loneliness in Urban Areas: Measuring Feasibility, Acceptability, and Benefits of a Community-based Intervention.
- ClinicalTrials.gov ID
- NCT06805136
- Acronym / sponsor ID
- QME24. 0657
- Conditions
- Loneliness
- Keywords
- Loneliness, Young adults, Social interaction, Community intervention, Urban, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Feb 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 this study is to evaluate the feasibility and acceptability of a new community-based programme designed to tackle loneliness for young and working-age adults. The programme focuses on encouraging social interactions and connections through offering community initiatives and activities, online spaces for interaction, and free or low-cost social events for young adults. Further aims of this study are to determine the cost-effectiveness of the programme.
Detailed description
Loneliness is associated with adverse mental and physical health outcomes. Most interventions are aimed at older adults even though young adults, including those of working-age, have been identified as being at-risk for persistent loneliness. This study aims to formatively evaluate the feasibility and acceptability of a community-based social interaction intervention. Therefore, the main objectives of this study are to:
- Assess the feasibility and acceptability of the community-based intervention.
- To determine the costs and effects related to the community-based intervention using quantitative feasibility study data and qualitative interviews with study participants.
In this mixed-methods two-arm randomised feasibility study with qualitative evaluation, participants will be randomly allocated to the community-based intervention over 12 weeks or to the wait-list control group. The intervention consists of weekly community social activities with the aim of reducing feelings of loneliness. Participants in the wait-list control group can continue any standard care or support they were receiving e.g. use of GP or mental health services. For both groups, online self-report assessments will take place at baseline (time 0, t0), 12-week follow-up (end of the intervention period; time 1, t1) and 6-weeks post intervention (18-weeks after baseline, time 2, t2). For the intervention group, an additional qualitative interview will be taken at the final timepoint (time 3, t3; 6 weeks post-intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based intervention group | Experimental | Behavioral: Community-based social interaction interventionThe participants in the community-based intervention group will be invited to attend weekly social activities over a period of 12 weeks. Participants must be committed to attend at least 8 activities during the 12 week period. Following the 12-week intervention period, the intervention group will enter a 6-week post-intervention period where they will no longer be encouraged to attend the activities to help understand the impact of stopping the intervention. |
| Wait-list control | No intervention | –The participants allocated to the wait-list control will continue to receive any standard care they were receiving (e.g., National Health Services (NHS) services) during the 18-week trial. All participants will be eligible and able to access the community-based intervention as independent members once the trial ends (after 18 weeks). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-40
- Reside in London
- Reports that they are some of the time or often lonely in response to a single questionnaire item ("How often do you feel lonely?)
- No prior interaction with the community-based intervention we are investigating
- Able to communicate in English sufficiently well to engage in qualitative interviews and complete the outcome measures and questionnaires.
Key exclusion criteria (8 listed)
- Age < 20 or age >40.
- Resides outside of London.
- Does not report frequent levels of loneliness ("hardly ever or never" in response to single questionnaire item).
- Previously attended any event or is an existing member of the community-based programme that is forming the intervention arm.
- Unable to communicate even with communication support.
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 |
|---|---|---|
| Community-based social interaction interventionThe intervention focuses on free or low-cost social interaction by offering community initiatives and activities, online spaces for interaction, and social events to young and working-age adults in London. Activities include but are not limited to social walks, bingo nights, board game afternoons and pub quizzes. | Behavioural | Community-based intervention group |
Primary outcome
Feasibility
Time frame: From enrollment to 6-weeks post-intervention (18 weeks total)
To determine feasibility, we will record: (i) Number of participants that complete the screening stage. (ii) Number of eligible participants following the screening. (iii) Number of participants who consent to take part in the intervention. (iv) Number of participants randomised. (v) Number of participants who drop out and reasons offered for this. (vi) During the intervention: range and average number of sessions completed as a proportion of those offered. Data completeness for each questionnaire will be summarised at each time point.
Acceptability
Time frame: 6-weeks post intervention
Qualitative interviews will be conducted to explore participants' experiences of the intervention, barriers and facilitators, perceived active ingredients, potential benefits, and suggested changes. They will also seek to understand the reach, engagement, and benefits of the intervention by focusing on topics around engagement, tolerability, and safety. The interviews will be conducted with the intervention group and facilitated using topic guides.
6 secondary outcomes
Loneliness
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Wellbeing
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Social connectedness
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Health Related Quality of Life
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Capability
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Client Service Receipt Inventory
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
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 27 Feb 2026.
- Background: PubMed 21598064Al-Janabi H, Flynn TN, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012 Feb;21(1):167-76. doi: 10.1007/s11136-011-9927-2. Epub 2011 May 20.
- Background: PubMed 34819104Shah N, Cader M, Andrews B, McCabe R, Stewart-Brown SL. Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): performance in a clinical sample in relation to PHQ-9 and GAD-7. Health Qual Life Outcomes. 2021 Nov 24;19(1):260. doi: 10.1186/s12955-021-01882-x.
- Background: PubMed 660402Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.
- Background: PubMed 38490911Bryan BT, Thompson KN, Goldman-Mellor S, Moffitt TE, Odgers CL, So SLS, Uddin Rahman M, Wertz J, Matthews T, Arseneault L. The socioeconomic consequences of loneliness: Evidence from a nationally representative longitudinal study of young adults. Soc Sci Med. 2024 Feb 22;345:116697. doi: 10.1016/j.socscimed.2024.116697. Online ahead of print.
- Background: PubMed 38654301Eager S, Johnson S, Pitman A, Uribe M, Qualter P, Pearce E. Young people's views on the acceptability and feasibility of loneliness interventions for their age group. BMC Psychiatry. 2024 Apr 23;24(1):308. doi: 10.1186/s12888-024-05751-x.
- Individual participant dataSharing planned: Yes. Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based social interaction intervention in people with Loneliness, run by Queen Mary University of London at 2 sites in United Kingdom.
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 6 inclusion and 8 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 27 Feb 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 United Kingdom. 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 Jennifer Lau (020 7882 3850, j.lau@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment to 6-weeks post-intervention (18 weeks total)). 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 NCT06805136, which also lists 5 linked publications.
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 27 Feb 2026.