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.
Autor: | Stefanidou T; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Ambler G; Department of Statistical Sciences, University College London, London, UK.; Priment Clinical Trials Unit, University College London, London, UK., Bartl G; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Barber N; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; The McPin Foundation, London, UK., Billings J; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Bogatsu T; Institute for Mental Health, University of Birmingham, Birmingham, UK., Carroll R; Tees, Esk and Wear Valley, NHS Foundation Trust, Durham, UK., Chipp B; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; The McPin Foundation, London, UK., Conneely M; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Downey AM; Priment Clinical Trials Unit, University College London, London, UK., Evlat G; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; Camden and Islington NHS Foundation Trust, London, UK., Hunter R; Priment Clinical Trials Unit, University College London, London, UK.; Department of Primary Care and Population Health, University College London, London, UK., Le Novere M; Priment Clinical Trials Unit, University College London, London, UK.; Department of Primary Care and Population Health, University College London, London, UK., Lewis G; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; Priment Clinical Trials Unit, University College London, London, UK.; Camden and Islington NHS Foundation Trust, London, UK., Mackay T; The McPin Foundation, London, UK., Marwaha S; Institute for Mental Health, University of Birmingham, Birmingham, UK., Matin Z; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Naughton G; The McPin Foundation, London, UK., Nekitsing C; School for Business and Society, University of York, York, UK., O'Sullivan M; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; Camden and Islington NHS Foundation Trust, London, UK., Pinfold V; The McPin Foundation, London, UK., Pan S; Department of Statistical Sciences, University College London, London, UK.; Priment Clinical Trials Unit, University College London, London, UK., Sobers A; Barnet, Enfield and Haringey, NHS Mental Health Trust, London, UK., Thompson KJ; The McPin Foundation, London, UK.; Tees, Esk and Wear Valley, NHS Foundation Trust, Durham, UK., Vasikaran J; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK., Webber M; School for Business and Society, University of York, York, UK., Johnson S; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.; Camden and Islington NHS Foundation Trust, London, UK., Lloyd-Evans B; Division of Psychiatry, University College London, Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. b.lloyd-evans@ucl.ac.uk. |
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Jazyk: | angličtina |
Zdroj: | Trials [Trials] 2023 Oct 06; Vol. 24 (1), pp. 652. Date of Electronic Publication: 2023 Oct 06. |
DOI: | 10.1186/s13063-023-07684-4 |
Abstrakt: | 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. (© 2023. BioMed Central Ltd., part of Springer Nature.) |
Databáze: | MEDLINE |
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