Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment resistant depression in secondary mental health services

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.

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.

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.

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.

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.

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.

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.