Lloyd-Evans Brynmor, Bone Jessica K, Pinfold Vanessa, Lewis Glyn, Billings Jo, Frerichs Johanna, Fullarton Kate, Jones Rebecca, Johnson Sonia
Division of Psychiatry, University College London, London, W1T 7NF, UK.
The McPin Foundation, London, SE1 0EH, UK.
Trials. 2017 Oct 23;18(1):493. doi: 10.1186/s13063-017-2226-7.
Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression. People with mental health problems are particularly vulnerable to loneliness and, for those with anxiety or depression, loneliness is associated with poorer outcomes. Interventions which support people to utilise existing networks and access new social contact are advocated in policy but there is little evidence regarding their effectiveness. People with mental health problems have potential to benefit from interventions to reduce loneliness, but evidence is needed regarding their feasibility, acceptability and outcomes. An intervention to reduce loneliness for people with anxiety or depression treated in secondary mental health services was developed for this study, which will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.
In this feasibility trial, 40 participants with anxiety or depression will be recruited through two secondary mental health services in London and randomised to an intervention (n = 30) or control group (n = 10). The control group will receive standard care and written information about local community resources. The coproduced intervention, developed in this study, includes up to ten sessions with a 'Community Navigator' over a 6-month period. Community Navigators will work with people individually to increase involvement in social activities, with the aim of reducing feelings of loneliness. Data will be collected at baseline and at 6-month follow-up - the end of the intervention period. The acceptability of the intervention and feasibility of participant recruitment and retention will be assessed. Potential primary and secondary outcomes for a future definitive trial will be completed to assess response and completeness, including measures of loneliness, depression and anxiety. Qualitative interviews with participants, staff and other stakeholders will explore experiences of Community Navigator support, the mechanisms by which it may have its effects and suggestions for improving the programme.
Our trial will provide preliminary evidence of the feasibility and acceptability of Community Navigator support and of trial procedures for testing this. The results will inform a future definitive randomised controlled trial of this intervention.
ISRCTN10771821 . Registered on 3 April 2017.
孤独与各年龄段人群的健康状况不佳有关，包括预期寿命缩短和患抑郁症的风险增加。有心理健康问题的人尤其容易感到孤独，对于那些患有焦虑症或抑郁症的人来说，孤独与更差的结果相关。政策提倡采取干预措施，支持人们利用现有社交网络并建立新的社会联系，但几乎没有证据表明这些措施的有效性。有心理健康问题的人有可能从减少孤独感的干预措施中受益，但需要有关其可行性、可接受性和效果的证据。本研究针对在二级心理健康服务机构接受治疗的焦虑症或抑郁症患者开发了一种减少孤独感的干预措施，并将通过随机对照试验来测试实施和评估该措施的可行性和可接受性。
在这项可行性试验中，将通过伦敦的两家二级心理健康服务机构招募40名患有焦虑症或抑郁症的参与者，并将其随机分为干预组（n = 30）或对照组（n = 10）。对照组将接受标准护理以及关于当地社区资源的书面信息。本研究中共同制定的干预措施包括在6个月内与一名“社区导航员”进行多达十次的会面。社区导航员将与人们单独合作，以增加他们对社交活动的参与度，目的是减少孤独感。将在基线和6个月随访时（干预期结束时）收集数据。将评估干预措施的可接受性以及参与者招募和留存的可行性。将完成未来确定性试验的潜在主要和次要结局评估，以评估反应情况和完整性，包括孤独感、抑郁和焦虑的测量指标。对参与者、工作人员和其他利益相关者进行定性访谈，将探讨社区导航员支持的体验、其可能产生效果的机制以及改进该计划的建议。
我们的试验将为社区导航员支持的可行性和可接受性以及测试该支持的试验程序提供初步证据。研究结果将为该干预措施未来的确定性随机对照试验提供参考。
ISRCTN10771821。于2017年4月3日注册。
