Establishing Social Connections in Urban Areas: Evaluating a Community-based Programme
ConditionLoneliness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Community-based social interaction intervention
BehavioralThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Community-based intervention groupExperimental treatment 1 intervention
Group B: Wait-list controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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 interventionSecondary outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
University of Exeter
Collaborator
Source ClinicalTrials.gov