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

被引：3

作者：

Stefanidou, Theodora ^{[1
]}

Ambler, Gareth ^{[2
,3
]}

Bartl, Gergely ^{[1
]}

Barber, Nick ^{[1
,4
]}

Billings, Jo ^{[1
]}

Bogatsu, Tumelo ^{[5
]}

Carroll, Richard ^{[6
]}

Chipp, Beverley ^{[1
,4
]}

Conneely, Maev ^{[1
]}

Downey, Anne-Marie ^{[3
]}

Evlat, Gamze ^{[1
,7
]}

Hunter, Rachael ^{[3
,8
]}

Le Novere, Marie ^{[3
,8
]}

Lewis, Glyn ^{[1
,3
,7
]}

Mackay, Tanya ^{[4
]}

Marwaha, Steven ^{[5
]}

Matin, Zubair ^{[1
]}

Naughton, Georgia ^{[4
]}

Nekitsing, Chandani ^{[9
]}

O'Sullivan, Millie ^{[1
,7
]}

Pinfold, Vanessa ^{[4
]}

Pan, Shengning ^{[2
,3
]}

Sobers, Angela ^{[10
]}

Thompson, Keith J. ^{[4
,6
]}

Vasikaran, Jerusaa ^{[1
]}

Webber, Martin ^{[9
]}

Johnson, Sonia ^{[1
,7
]}

Lloyd-Evans, Brynmor ^{[1
]}

机构：

[1] UCL, Div Psychiat, Maple House,149 Tottenham Court Rd, London W1T 7NF, England

[2] UCL, Dept Stat Sci, London, England

[3] UCL, Priment Clin Trials Unit, London, England

[4] McPin Fdn, London, England

[5] Univ Birmingham, Inst Mental Hlth, Birmingham, England

[6] NHS Fdn Trust, Tees Esk & Wear Valley, Durham, England

[7] Camden & Islington NHS Fdn Trust, London, England

[8] UCL, Dept Primary Care & Populat Hlth, London, England

[9] Univ York, Sch Business & Soc, York, England

[10] NHS Mental Hlth Trust, Barnet Enfield & Haringey, London, England

来源：

TRIALS | 2023年 / 24卷 / 01期

关键词：

Loneliness; Depression; Community navigator; Randomised controlled trial; STAR-ASTERISK-D; LONG-TERM; SCALE; CARE; DISORDER; VALIDITY; OUTCOMES; ANXIETY; PEOPLE; PHQ-9;

D O I：

10.1186/s13063-023-07684-4

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundNew 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.MethodsA 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.DiscussionThis 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 registrationProspectively registered on 8th July 2022 at: ISRCTN13205972.

引用

页数：15

共 47 条

[11] Social and emotional loneliness: A reexamination of Weiss' typology of loneliness [J].

DiTommaso, E ;

Spinner, B .

PERSONALITY AND INDIVIDUAL DIFFERENCES, 1997, 22 (03) :417-427

[12] Prospective, long-term, multicenter study of the naturalistic outcomes of patients with treatment-resistant depression [J].

Dunner, David L. ;

Rush, A. John ;

Russell, James M. ;

Burke, Michael ;

Woodard, Stacy ;

Wingard, Peggy ;

Allen, John .

JOURNAL OF CLINICAL PSYCHIATRY, 2006, 67 (05) :688-695

[13] What happens to patients with treatment-resistant depression? A systematic review of medium to long term outcome studies [J].

Fekadu, Abebaw ;

Wooderson, Sarah C. ;

Markopoulo, Kalypso ;

Donaldson, Catherine ;

Papadopoulos, Andrew ;

Cleare, Anthony J. .

JOURNAL OF AFFECTIVE DISORDERS, 2009, 116 (1-2) :4-11

[14] Influences on participation in a programme addressing loneliness among people with depression and anxiety: findings from the Community Navigator Study [J].

Frerichs, Johanna ;

Billings, Jo ;

Barber, Nick ;

Chhapia, Anjie ;

Chipp, Beverley ;

Shah, Prisha ;

Shorten, Anna ;

Stefanidou, Theodora ;

Johnson, Sonia ;

Evans, Brynmor Lloyd ;

Pinfold, Vanessa .

BMC PSYCHIATRY, 2020, 20 (01)

[15] Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial [J].

Giacco, Domenico ;

Chevalier, Agnes ;

Patterson, Megan ;

Hamborg, Thomas ;

Mortimer, Rianna ;

Feng, Yan ;

Webber, Martin ;

Xanthopoulou, Penny ;

Priebe, Stefan .

BMJ OPEN, 2021, 11 (12)

[16]

GOV.UK, Good Clinical Practice for clinical trials

[17] GROUPS 4 HEALTH Reduces Loneliness and Social Anxiety in Adults With Psychological Distress: Findings From a Randomized Controlled Trial [J].

Haslam, Catherine ;

Cruwys, Tegan ;

Chang, Melissa X-L ;

Bentley, Sarah, V ;

Haslam, S. Alexander ;

Dingle, Genevieve A. ;

Jetten, Jolanda .

JOURNAL OF CONSULTING AND CLINICAL PSYCHOLOGY, 2019, 87 (09) :787-801

[18] Social Identity, Health and Well-Being: An Emerging Agenda for Applied Psychology [J].

Haslam, S. Alexander ;

Jetten, Jolanda ;

Postmes, Tom ;

Haslam, Catherine .

APPLIED PSYCHOLOGY-AN INTERNATIONAL REVIEW-PSYCHOLOGIE APPLIQUEE-REVUE INTERNATIONALE, 2009, 58 (01) :1-23

[19] A SHORT-FORM MEASURE OF LONELINESS [J].

HAYS, RD ;

DIMATTEO, MR .

JOURNAL OF PERSONALITY ASSESSMENT, 1987, 51 (01) :69-81

[20] The effectiveness of psychological interventions for loneliness: A systematic review and meta-analysis [J].

Hickin, Nisha ;

Kall, Anton ;

Shafran, Roz ;

Sutcliffe, Sebastian ;

Manzotti, Grazia ;

Langan, Dean .

CLINICAL PSYCHOLOGY REVIEW, 2021, 88

← 1 2 3 4 5 →