Abstract
BackgroundLoneliness 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.MethodsIn 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.DiscussionOur 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.Trial registrationISRCTN10771821. Registered on 3 April 2017.
Highlights
Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression
Loneliness predicts the onset of anxiety [10] and depression [11]
The aim of this study is to develop and test the feasibility and acceptability of a programme of support for people with complex depression and anxiety and to examine the feasibility of a randomised controlled trial (RCT) of this intervention
Summary
Design The study is a feasibility trial with block randomisation conducted in two sites in London (United Kingdom). These measures were chosen by the working group after extensive discussion balancing data collection needs and respondent burden They aim to capture dimensions which support from a Community Navigator may improve including mental health symptoms (depression, anxiety), social outcomes (loneliness, social network, social capital), day-to-day activity and general wellbeing (mental wellbeing, quality of life). Members of the team who will be carrying out the interviews with participants have personal experience of depression and anxiety, and topic guides for all qualitative work will be coproduced with the study working group These interviews will explore people’s experiences of the programme, including: The content of sessions with Community Navigators The impact of being part of the programme How the programme proved helpful Challenges around being part of the programme Suggested improvements to the programme. Any adverse events assessed as study-related will be reported, with the trial steering committee chair’s recommendation, to the study sponsor
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