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Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment resistant depression in secondary mental health services
Trial Summary
The aim of the trial is to evaluate an innovative social intervention for people with treatment-resistant depression (TRD) in secondary care. People with TRD are only partially helped by current treatments available and often extremely lonely. The focus of the programme is to reduce loneliness in those with TRD. Participants shall be randomly allocated to receive treatment as usual, or receive support from a ‘Community Navigator’, who they will meet up to 10 sessions of 1:1 support and attend at up to four participant group “meet-ups” over an eight-month period. The purpose of this is to increase the participant’s social activities and community engagement. This is the intended means to reduce depression and achieve other health and social benefits. Further aims of the Community Navigator trial is to determine the cost-effectiveness of the Community Navigator programme, and to explore its impact, how benefits were achieved, and key considerations for its provision in NHS settings.
Participants included in the trial will be assessed at four time-points:
- Baseline (this is when randomisation to the Community Navigator programme or treatment as usual will occur)
- 4-month follow-up
- 8-month follow-up (end of treatment for those on the Community Navigator programme)
- 11-month follow-up
- 14-month follow-up
Participants will be assessed using validated questionnaires, which have been chosen to assess levels of depression and loneliness. In addition to this, questionnaires which have been made for the trial will assess the cost effectiveness of the Community Navigator programme compared to regular treatment available on the NHS. For further information on the specific questionnaires used, please view the Publications tab for access to the trial protocol.
The trial is run out of four sites across England. For more information on the sites and trial team, please visit the Staff and Sites tab.
Sponsor and Funding
The trial is sponsored by Camden and Islingson NHS Foundation Trust, and funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.
