An interventional study of Community-based social interaction intervention in Loneliness, sponsored by Queen Mary University of London. Recruiting at 2 sites in United Kingdom. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
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.
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:
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).
Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Community-based social interaction 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).
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.
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.
Time frame: 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.
Time frame: 6-weeks post intervention
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
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).
Plan to share: Yes — Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge.
Supporting information: Study protocol
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Queen Mary University of London