The Community Navigator trial
Research type
Research Study
Full 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
IRAS ID
309178
Contact name
Brynmor Lloyd-Evans
Contact email
Sponsor organisation
Camden & Islington NHS Foundation Trust
ISRCTN Number
ISRCTN13205972
Clinicaltrials.gov Identifier
UCL Data Protection registration number, Z6364106/2021/12/35
Duration of Study in the UK
2 years, 8 months, 28 days
Research summary
About a third of people with depression are not helped by anti-depressants and can be termed “treatment resistant” (TRD). Talking therapies are also of limited benefit for this group. Among people with TRD only 2-3 out of 10 recovers over a few years. They are enduringly unwell and often extremely lonely. More research and new types of support are urgently needed for this group. Our research team has previously developed and tested the feasibility of a programme of support, the Community Navigator programme, in addressing loneliness for people with complex depression and anxiety.\n\nIn this study, we propose a full trial in four areas of England to test the effectiveness of the Community Navigator programme, in reducing loneliness and depression for people with TRD in secondary care. This is a 33-month trial with a built-in review point after the first six months. 306 people will be allocated at random to get support from a Community Navigator to increase their social activities and community engagement 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.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0064
Date of REC Opinion
31 Mar 2022
REC opinion
Further Information Favourable Opinion