Background
Aims
Methods
Design
Study period | ||||
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Timepoint | Enrolment | Allocation | Treatment period (6 months) | Follow-up (end of treatment period; 6 months) |
Enrolment: | ||||
Eligibility screen | X | |||
Informed consent | X | |||
Randomisation | X | |||
Intervention: | ||||
Community Navigation | X | |||
Control | X | |||
Assessments: | ||||
Baseline outcome measures | X | |||
Sociodemographic characteristics | ||||
Trust Informatics information | ||||
De Jong Gierveld Loneliness Scale | ||||
Lubben Social Network Scale | ||||
Resource Generator UK | ||||
Time Budget Diary | ||||
WEMWBS | ||||
Patient Health Questionnaire | ||||
Generalised Anxiety Disorder Questionnaire | ||||
EQ-5D-5 L | ||||
Recovering Quality of Life Questionnaire | ||||
Process recording | X | |||
Community Navigator session logs | ||||
Participant feedback phone calls | ||||
Follow-up outcome measures | X | |||
Sociodemographic characteristics | ||||
Trust Informatics information | ||||
De Jong Gierveld Loneliness Scale | ||||
Lubben Social Network Scale | ||||
Resource Generator UK | ||||
Time Budget Diary | ||||
WEMWBS | ||||
Patient Health Questionnaire | ||||
Generalized Anxiety Disorder Questionnaire | ||||
EQ-5D-5 L | ||||
Recovering Quality of Life Questionnaire | ||||
Qualitative interview | X | X |
Setting
Participants
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Currently on the caseload of a secondary mental health service for people with depression or anxiety
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Aged 18 years or older
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Score at least 2 on the six-item De Jong Gierveld Loneliness Scale [27] at initial screening
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People who do not have capacity to consent to participate
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People who pose a risk of harm to others (as judged by their care coordinator) such that meetings with a researcher or Community Navigator are not recommended
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People who are unable to communicate in English. Resources were not available to deliver this early stage intervention in other languages
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People who are currently an inpatient at a mental health or general hospital or using mental health crisis services
Randomisation
The intervention
Development
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Current academic literature presented to the working group by the research team. As part of a related review, a scoping review of the academic literature was performed to identify existing interventions targeting loneliness and the evidence base for these interventions [19]. Academic literature describing models of loneliness and the theoretical basis for interventions targeting loneliness [30] was also reviewed and presented to the working group
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Consultations carried out by the research team within the two local services (CDAT and CCT) with current service users and clinicians to understand their views on loneliness and what intervention might be useful. This information was presented to the working group
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Meetings by the research team with the Groups 4 Health programme team [33] to explore a potential group intervention for our Community Navigation programme
Theoretical basis
Principles of Community Navigation
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Socially focused – Community Navigators will focus exclusively on support to enhance an individual’s social world, working with people to feel more engaged and connected to other people, activities, and their community
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Asset-based – Community Navigators are champions of the community. They will continually seek to develop their knowledge of the local community and use this to connect individuals to resources that help to promote and sustain wellbeing
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Solution-focused [38] – together with people they are supporting, Community Navigators will seek to identify the next step towards achieving their goals. The approach is future-focused, looking for positive solutions using the person’s strengths and resources rather than concentrating on the past or what is preventing the person from moving forward [38]
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Person-centred – support will be individualised, focussing on the needs, goals, and preferences of the individual at each point in their recovery. Community Navigators will work collaboratively ‘with’ the person rather than doing things ‘to’ or ‘for’ the person
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Non-directive – Community Navigators will have their own ideas, goals and agenda, but these will be secondary to those of the person they are supporting, who will direct the pace and direction of their journey together
Intervention outline
The Community Navigators
The control group
Outcome measures
Procedure
Measures
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The De Jong Gierveld Loneliness Scale is an 11-item, self-report measure of loneliness, yielding a total score and subscale scores for social and emotional loneliness [41].
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The Lubben Social Network Scale is a six-item self-report measure assessing quantity and quality of contact with family and friends [42].
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The Resource Generator UK is a 27-item measure of perceived access to social capital [43].
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The Time Budget Diary is a retrospective self-report measure of activity over the previous week [44]. Additional questions have been added to this measure so that participants are asked whether activities were done with others or alone and, if with others, whether this was online, phone or face-to-face. These additions will allow us to distinguish activity involving social contact from other activity.
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The Warwick-Edinburgh Mental Well-being Scale is a 14-item self-report scale of mental wellbeing [45].
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The Patient Health Questionnaire (PHQ-9)is a nine-item self-report measure of depression [46].
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The Generalized Anxiety Disorder Questionnaire is a seven-item self-report measure of anxiety [47].
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The EQ-5D-5 L is a five-item self-report health outcome measure [48].
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The Recovering Quality of Life Questionnaire is a 10-item self-report measure of quality of life developed for use across all mental health populations [49].
Qualitative interviews
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The content of sessions with Community Navigators
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The impact of being part of the programme
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How the programme proved helpful
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Challenges around being part of the programme
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Suggested improvements to the programme
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Assumptions - the context in which the programme is taking place and how it will work
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Inputs - the resources put in to deliver the programme
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Activities - the content of the programme
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Enablers - factors facilitating the delivery of programme outcomes
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Intermediate outcomes – the shorter-term changes or impacts of the programme
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Final goals – the broader-longer term aims of the programme