Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment-resistant depression in secondary community mental health services: trial protocol
Theodora Stefanidou,
Gareth Ambler,
Gergely Bartl,
Nick Barber,
Jo Billings,
Tumelo Bogatsu,
Richard Carroll,
Beverley Chipp,
Maev Conneely,
Anne-Marie Downey,
Gamze Evlat,
Rachael Hunter,
Marie Le Novere,
Glyn Lewis,
Tanya Mackay,
Steven Marwaha,
Zubair Matin,
Georgia Naughton,
Chandani Nekitsing,
Millie O’Sullivan,
Vanessa Pinfold,
Shengning Pan,
Angela Sobers,
Keith J. Thompson,
Jerusaa Vasikaran,
Martin Webber,
Sonia Johnson,
Brynmor Lloyd-Evans
Affiliations
Theodora Stefanidou
Division of Psychiatry, University College London
Gareth Ambler
Department of Statistical Sciences, University College London
Gergely Bartl
Division of Psychiatry, University College London
Nick Barber
Division of Psychiatry, University College London
Jo Billings
Division of Psychiatry, University College London
Tumelo Bogatsu
Institute for Mental Health, University of Birmingham
Richard Carroll
Tees, Esk and Wear Valley, NHS Foundation Trust
Beverley Chipp
Division of Psychiatry, University College London
Maev Conneely
Division of Psychiatry, University College London
Anne-Marie Downey
Priment Clinical Trials Unit, University College London
Gamze Evlat
Division of Psychiatry, University College London
Rachael Hunter
Priment Clinical Trials Unit, University College London
Marie Le Novere
Priment Clinical Trials Unit, University College London
Glyn Lewis
Division of Psychiatry, University College London
Tanya Mackay
The McPin Foundation
Steven Marwaha
Institute for Mental Health, University of Birmingham
Zubair Matin
Division of Psychiatry, University College London
Georgia Naughton
The McPin Foundation
Chandani Nekitsing
School for Business and Society, University of York
Millie O’Sullivan
Division of Psychiatry, University College London
Vanessa Pinfold
The McPin Foundation
Shengning Pan
Department of Statistical Sciences, University College London
Angela Sobers
Barnet, Enfield and Haringey, NHS Mental Health Trust
Keith J. Thompson
The McPin Foundation
Jerusaa Vasikaran
Division of Psychiatry, University College London
Martin Webber
School for Business and Society, University of York
Abstract Background New treatments are needed for people with treatment-resistant depression (TRD), who do not benefit from anti-depressants and many of whom do not recover fully with psychological treatments. The Community Navigator programme was co-produced with service users and practitioners. It is a novel social intervention which aims to reduce loneliness and thus improve health outcomes for people with TRD. Participants receive up to 10 individual meetings with a Community Navigator, who helps them to map their social world and set and enact goals to enhance their social connections and reduce loneliness. Participants may also access group meet-ups with others in the programme every 2 months, and may be offered modest financial support to enable activities to support social connections. Methods A researcher-blind, multi-site, 1:1 randomised controlled trial with N = 306 participants will test the effectiveness of the Community Navigator programme for people with TRD in secondary community mental health teams (CMHTs). Our primary hypothesis is that people who are offered the Community Navigator programme as an addition to usual CMHT care will be less depressed, assessed using the PHQ-9 self-report measure, at 8-month, end-of-treatment follow-up, compared to a control group receiving usual CMHT care and a booklet with information about local social groups and activities. We will follow participants up at end-of-treatment and at 14 months, 6 months after end-of-treatment follow-up. Secondary outcomes include the following: loneliness, anxiety, personal recovery, self-efficacy, social network, social identities. We will collect data about health-related quality of life and service use to investigate the cost-effectiveness of the Community Navigator programme. Discussion This trial will provide definitive evidence about the effectiveness and cost-effectiveness of the Community Navigator programme and whether it can be recommended for use in practice. The trial is due to finish in August 2025. Trial registration Prospectively registered on 8th July 2022 at: ISRCTN13205972.
