Establishing Social Connections in Urban Areas: Evaluating a Community-based Programme

Not Applicable

Recruiting

• Conditions: Loneliness

• Registration Number: NCT06805136
• Lead Sponsor: Queen Mary University of London

Brief 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 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:

1. Assess the feasibility and acceptability of the community-based intervention.

2. 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 Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Study Start: 2025-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-05
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility	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	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.

Secondary Outcome Measures

Name	Time	Method
Loneliness	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	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
Wellbeing	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	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.
Social connectedness	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	The Social Connectedness Scale (SCS). This SCS scale measures connectedness using 20 items measuring belongingness, on a 6-point Likert scale.
Health Related Quality of Life	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	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.
Capability	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	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.
Client Service Receipt Inventory	Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).	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.

Trial Locations

Locations (2)

In the community in London, England; 🇬🇧 London, United Kingdom

Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of London; 🇬🇧 London, United Kingdom