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Recruiting NCT06805136

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

No phase Interventional Loneliness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community-based social interaction intervention.
Who it may be relevant to
Registry conditions: Loneliness. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Tackling Youth Loneliness in Urban Areas: Measuring Feasibility, Acceptability, and Benefits of a Community-based Intervention.

Overview

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).

Interventions

  • Behavioral Community-based social interaction intervention
    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.

Primary outcome measures

  • Feasibility [Time frame: From enrollment to 6-weeks post-intervention (18 weeks total)]
  • Acceptability [Time frame: 6-weeks post intervention]
Secondary outcome measures (6)
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 2 centers
  • In the community in London, England — London
  • Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of Lo — London

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. PMID 21598064
  • Shah 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. PMID 34819104
  • Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11. PMID 660402
  • Bryan 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. PMID 38490911
  • Eager 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. PMID 38654301

Identifiers

NCT: NCT06805136 · QME24. 0657 · APP19330

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗