Title: Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment resistant depression in secondary mental health services
Funder: Department of Health and Social Care

Abstract: Background: Loneliness is harmful for physical and mental health and common among people with mental health problems. In particular, people who are depressed recover less well if they are also lonely. We lack evidence about how best to help people with severe, long-term mental health problems to develop and sustain valued social connections and be less lonely. Mental health services often provide less support with this area of life than service users would like. _x000D_ _x000D_ The Community Navigator programme: In our previous research, service users, mental health staff and researchers together developed the Community Navigator programme, which aims to reduce loneliness for people with depression who are using community mental health services. This group have typically been very unwell for a long time and have multiple health and social needs. They are often extremely lonely, and are only partially helped by current treatments. New types of support are needed. The programme involves offering people ten meetings with a “Community Navigator” over a six-month period, to discuss people, places and activities which are important to them, and to develop and achieve goals for enhancing social connections and reducing loneliness. There are also “meet-ups” for people in the programme to share experiences of local groups and resources, and strategies for reducing loneliness. Community Navigators bring a fresh approach which complements clinical care: they are recruited and trained to be experts in their local communities and in actively helping people participate in social groups and activities. Our previous research established the programme was welcomed by participants and the mental health teams taking part, and that we could run a trial to evaluate it. It looks promising as a way to help with depression by reducing people’s loneliness._x000D_ _x000D_ The study plans: In this application, we propose a full trial in four areas of England to test the effectiveness of the Community Navigator programme, in a 3 and-a-half year study with a built-in review point after 18 months. 306 people will be allocated at random to get support from a Community Navigator in addition to their usual community mental health team care; or to carry on receiving treatment as usual. We will ask all the participants to complete research questionnaires with a researcher when they agree to take part, eight months later (once the Navigator support has ended), and again six months after that. Our main question is whether people in the group offered the Community Navigator support are less depressed at eight months follow-up than people in the comparison group. We will also assess loneliness, anxiety and people’s personal recovery at each time point, and look at whether the programme is good value for money. A peer researcher will do in-depth interviews with people receiving the programme, the Navigators and their supervisors, to understand how any benefits for people are achieved, and what helps the programme work well in an NHS context. _x000D_ _x000D_ Our study team has varied expertise, including researchers, mental health staff and people living with mental health problems. An eight-member service user group will advise on the project._x000D_ _x000D_ What the study will achieve: If successful, our study will establish an evidence-based type of social support to help people with severe long-term depression, which can complement the medical and psychological treatments already on offer in mental health services

Lay abstract: Background: Clinical outcomes are poor for people with Treatment Resistant Depression (TRD); existing medical and psychological treatments have limited benefit. Loneliness predicts poor symptom outcomes for depression: it offers a novel intervention target for TRD. The Community Navigator programme addresses loneliness for people with TRD in secondary care. It involves, over 6 months, ten individual meetings with a Community Navigator and group sessions, helping people to map their social world, make and enact plans to improve their social relationships. The programme has demonstrated feasibility: a definitive trial of its effectiveness is required. _x000D_ _x000D_ Aims: An individual randomised controlled trial will test whether the Community Navigator programme reduces depression for people with TRD in secondary mental health services. We will also evaluate its effect on loneliness and other outcomes, its cost-effectiveness, and explore its perceived impact and key considerations for delivering the programme in NHS settings._x000D_ _x000D_ Methods: We will recruit N=306 participants from community mental health teams at 4 NHS sites in England. Participants will be aged 18+ using participating services and will meet screening criteria for TRD and loneliness. Eligible consenting participants will be randomised to the Community Navigator programme, or to receive an information booklet about local resources – both in addition to routine care. An internal pilot during the first six months of recruitment will set continuation criteria based on recruitment rates per site per month._x000D_ _x000D_ Our primary hypothesis is that depression, measured using the PHQ-9, will be lower for the intervention group compared to controls at end-of-treatment 8-month follow-up. Secondary outcomes are loneliness, anxiety, personal recovery, and proximal intervention outcomes of social network, activity, social identity, self-stigma and self-efficacy. All outcome measures will be completed through structured interviews at baseline, 8 month (end-of treatment) and 14 month (six months post end-of-treatment) follow-ups. Service use data will be collected from participants and NHS health records. _x000D_ _x000D_ The primary intention-to-treat analysis will use multilevel linear regression models adjusting for baseline PHQ-9 score and site using fixed effects, and with a random effect of community navigator. The intervention effect will be estimated with a 95% confidence interval and p value. Economic analyses will calculate the incremental cost per quality adjusted life year gained of Community Navigators plus routine care compared to routine care over 14 months. _x000D_ Qualitative interviews will be conducted with two different sets of participants (n=20) and Navigators and supervisors: 1) during the internal pilot to explore barriers to recruitment and engagement; 2) at participants’ completion of the programme, to explore, in conjunction with Navigators’ session logs, intervention implementation and experience. _x000D_ _x000D_ Timeline and anticipated impact: The 42-month study will run from September 2021 – February 2025. The trial will provide high quality evidence regarding the effectiveness and cost-effectiveness of the Community Navigator programme, which, if successful, will support its recommendation in clinical guidelines and adoption within NHS mental health services to improve care for people with TRD. Findings will be publicised through scientific papers, blogs, presentations and an infographic. We will develop a guide to support future provision of the programme in the NHS.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH