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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression

Authors: Brynmor Lloyd-Evans, Jessica K. Bone, Vanessa Pinfold, Glyn Lewis, Jo Billings, Johanna Frerichs, Kate Fullarton, Rebecca Jones, Sonia Johnson

Published in: Trials | Issue 1/2017

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Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ISRCTN10771821. Registered on 3 April 2017.
Appendix
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Metadata
Title
The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression
Authors
Brynmor Lloyd-Evans
Jessica K. Bone
Vanessa Pinfold
Glyn Lewis
Jo Billings
Johanna Frerichs
Kate Fullarton
Rebecca Jones
Sonia Johnson
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2226-7

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