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| ID | Type | Description | Link |
|---|---|---|---|
| APP19330 | Other Identifier | Economic and Social Research Council (ESRC) - UKRI |
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| Name | Class |
|---|---|
| University of Exeter | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based social interaction intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lau | Contact | 020 7882 3850 | j.lau@qmul.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| In the community in London, England | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21598064 | Background | 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. | |
| 34819104 | Background | 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. |
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Participants' anonymised data may be shared with other research scientists for the purposes of research and knowledge.
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.
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.
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| 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. | 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. | 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. | 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. | 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. | Start of the intervention (baseline), end of intervention follow-up (12-weeks), 6-weeks post intervention (18 weeks). |
| Youth Resilience Unit, Wolfson Institute of Population Health, Queen Mary University of London | Not yet recruiting | London | United Kingdom |
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| 660402 | Background | 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. |
| 38490911 | Background | 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. |
| 38654301 | Background | 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. |