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
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...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07684-4 |
| _version_ | 1827633178349666304 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Theodora Stefanidou |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T14:55:54Z |
| format | Article |
| id | doaj.art-2e6bb38ba0064a87bf563c0e48b1956b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:55:54Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2e6bb38ba0064a87bf563c0e48b1956b2023-11-26T14:09:26ZengBMCTrials1745-62152023-10-0124111510.1186/s13063-023-07684-4Randomised 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 protocolTheodora Stefanidou0Gareth Ambler1Gergely Bartl2Nick Barber3Jo Billings4Tumelo Bogatsu5Richard Carroll6Beverley Chipp7Maev Conneely8Anne-Marie Downey9Gamze Evlat10Rachael Hunter11Marie Le Novere12Glyn Lewis13Tanya Mackay14Steven Marwaha15Zubair Matin16Georgia Naughton17Chandani Nekitsing18Millie O’Sullivan19Vanessa Pinfold20Shengning Pan21Angela Sobers22Keith J. Thompson23Jerusaa Vasikaran24Martin Webber25Sonia Johnson26Brynmor Lloyd-Evans27Division of Psychiatry, University College LondonDepartment of Statistical Sciences, University College LondonDivision of Psychiatry, University College LondonDivision of Psychiatry, University College LondonDivision of Psychiatry, University College LondonInstitute for Mental Health, University of BirminghamTees, Esk and Wear Valley, NHS Foundation TrustDivision of Psychiatry, University College LondonDivision of Psychiatry, University College LondonPriment Clinical Trials Unit, University College LondonDivision of Psychiatry, University College LondonPriment Clinical Trials Unit, University College LondonPriment Clinical Trials Unit, University College LondonDivision of Psychiatry, University College LondonThe McPin FoundationInstitute for Mental Health, University of BirminghamDivision of Psychiatry, University College LondonThe McPin FoundationSchool for Business and Society, University of YorkDivision of Psychiatry, University College LondonThe McPin FoundationDepartment of Statistical Sciences, University College LondonBarnet, Enfield and Haringey, NHS Mental Health TrustThe McPin FoundationDivision of Psychiatry, University College LondonSchool for Business and Society, University of YorkDivision of Psychiatry, University College LondonDivision of Psychiatry, University College LondonAbstract 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.https://doi.org/10.1186/s13063-023-07684-4LonelinessDepressionCommunity navigatorRandomised controlled trial |
| spellingShingle | 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 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 Trials Loneliness Depression Community navigator Randomised controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Loneliness Depression Community navigator Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-023-07684-4 |
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