NCT06805136

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2025Jun 2028

First Submitted

Initial submission to the registry

January 9, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 12, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

January 9, 2025

Last Update Submit

February 26, 2026

Conditions

Loneliness

Keywords

LonelinessYoung adultsSocial interactionCommunity interventionUrbanFeasibilityAcceptability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6-weeks post intervention

Secondary Outcomes (6)

  • Loneliness

    Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).

  • Wellbeing

    Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).

  • Social connectedness

    Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).

  • Health Related Quality of Life

    Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).

  • Capability

    Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks).

  • +1 more secondary outcomes

Study Arms (2)

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.

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).

Interventions

Community-based social interaction interventionBEHAVIORAL

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.

Community-based intervention group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

In the community in London, England

London, United Kingdom

RECRUITING

Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of London

London, United Kingdom

NOT YET RECRUITING

Related Publications (5)

  • 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: 21598064BACKGROUND

  • 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: 34819104BACKGROUND

  • 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: 660402BACKGROUND

  • 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: 38490911BACKGROUND

  • 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: 38654301BACKGROUND

Central Study Contacts

Jennifer Lau

CONTACT

020 7882 3850j.lau@qmul.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

February 3, 2025

Study Start

February 12, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge.

Shared Documents
STUDY PROTOCOL
Time Frame
Fully anonymised and non-identifiable study data will be available 6 months following the project's end, and will be kept by the PI for at least 10 years in the approved long-term repository in the UK.
Access Criteria
Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge. This data will not be able to be traced back to participants. The datasets will be available upon request from Professor Jennifer Lau, who is the lead researcher.

Locations

GB(2)