The Community Navigator trial to reduce loneliness and depression in adults with depression that does not respond to drug treatment
| ISRCTN | ISRCTN13205972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13205972 |
| IRAS number | 309178 |
| Secondary identifying numbers | CPMS 52174, NIHR131647, IRAS 309178 |
- Submission date
- 24/06/2022
- Registration date
- 08/07/2022
- Last edited
- 28/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
About a third of people with depression are not helped by anti-depressants and can be termed “treatment resistant” (TRD). Talking therapies are also of limited benefit for this group. Among people with TRD only 2-3 out of 10 recovers over a few years. They are enduringly unwell and often extremely lonely. More research and new types of support are urgently needed for this group. Our research team has previously developed and tested the feasibility of a programme of support, the Community Navigator programme, in addressing loneliness for people with complex depression and anxiety.
In this study, we propose a full trial in four areas of England to test the effectiveness of the Community Navigator programme, in reducing loneliness and depression for people with TRD in secondary care.
Who can participate?
Adults aged 18 years or older, with treatment-resistant depression
What does the study involve?
This is a 33-month trial with a built-in review point after the first six months. 306 people will be allocated at random to get support from a Community Navigator to increase their social activities and community engagement in addition to their usual community mental health team care; or to carry on receiving treatment as usual. We will ask all the participants to complete research questionnaires with a researcher when they agree to take part, eight months later (once the Navigator support has ended), and again six months after that. Our main question is whether people in the group offered the Community Navigator support are less depressed at eight months follow-up than people in the comparison group. We will also assess loneliness, anxiety and people’s personal recovery at each time point, and look at whether the programme is good value for money. A peer researcher will do in-depth interviews with people receiving the programme, the Navigators and their supervisors, to understand how any benefits for people are achieved, and what helps the programme work well in an NHS context.
What are the possible benefits and risks of participating?
Possible benefits of participating: We hope that having support from a Community Navigator will reduce feelings of loneliness and improve quality of life and health. Reading through the written information about local resources and community activities may also be useful. People in both groups will be involved in a study which will help to find out more about what kind of support is helpful for people with long-term depression who are experiencing feelings of loneliness.
Potential disadvantages of participating: It is possible that people will not find receiving support from the Community Navigator or the written information about local resources helpful, and this could be disappointing. Making a plan to increase your social connections with others could be very useful but some participants may find it challenging.
Where is the study run from?
Camden and Islington NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2021 to December 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Brynmor Lloyd-Evans, b.lloyd-evans@ucl.ac.uk
Contact information
Principal Investigator
Division of Psychiatry
University College London
Maple House
149 Tottenham Court Rd
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0001-9866-788X |
|---|---|
| b.lloyd-evans@ucl.ac.uk |
Scientific
Division of Psychiatry
University College London
Maple House
149 Tottenham Court Rd
London
W1T 7NF
United Kingdom
| ORCID ID |
0000-0002-5947-1304 |
|---|---|
| g.bartl@ucl.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 41975 PIS v2.0 22MAR2022.pdf |
| Scientific title | Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment resistant depression in secondary mental health services |
| Study objectives | People in the group offered the Community Navigator support will be less depressed at eight months follow-up than people in the comparison group |
| Ethics approval(s) | Approved 30/03/2022, South Central - Oxford B Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 207 1048199; oxfordb.rec@hra.nhs.uk), ref: 22/SC/0064 |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Current interventions as of 28/11/2024: This is a researcher-blind, randomised controlled trial with two arms. Staff in participating NHS services will briefly describe the study to potentially eligible service users and refer participants who are interested in taking part and agree to be referred to the study research team. A study researcher will provide an information sheet and discuss the study further with potential participants; then take formal consent from those who wish to take part. All consenting, potential participants will then be screened by researchers for loneliness and meeting treatment resistant depression criteria. Baseline measures will then be completed with those who are eligible, who will then be enrolled in the study and allocated at random to the treatment or the control group. The Trial Manager or administrator will inform the person's GP and care team that they are taking part in the trial, and will inform the participant which trial arm they are allocated to, and will inform the Community Navigators' supervisors of all participants randomized to the intervention arm, who require allocation to a Community Navigator. We aim to recruit 306 service users to take part in the trial, from four NHS sites in London, Birmingham and Yorkshire. We anticipate this recruitment will take 16 months, from June 2022 to September 2023. Update: Recruitment was slower than planned. To address these two new London sites we brought on to meet our recruitment target, and we applied for an extension which was given. We had 6 recruitment sites, 4 of which were in London and recruited 314 participants by 31 July 2024. Each participant receiving the study intervention will receive up to ten 1:1 meetings with a Community Navigator as well as up to four “meet-ups” open to all participants over an 8-month period. The "meet-ups" will run alongside the intervention, facilitated by the Community Navigators. Participants will receive the study intervention in addition to routine care from a specialist community mental health team (CMHT). The control group will receive routine CMHT care plus written information about local social resources. Routine care for both trial groups includes reviews by a psychiatrist and, typically, regular meetings with a care coordinator and where indicated, psychological therapy. Assessments for all participants will be performed by blinded researchers at the time of consent (baseline), 8-month (end of treatment) and 14 month (six months after end of treatment). Baseline measures will be performed at the screening visit. Additional depression and loneliness ratings will be collected through a self-completed online form or through a phone or video call with a study researcher at 4 and 11 months. We will collect qualitative data from selected, consenting participants and intervention providers at two stages: a) Qualitative study 1: during the internal pilot phase, to understand any barriers to trial recruitment and intervention engagement, using an anonymised online survey for all participants who agree to be contacted about this (Qualitative study 1a) and semi-structured interviews with 20 participants from the treatment group (Qualitative study 1b); and b) Qualitative study 2: with 20 intervention group participants later in the trial, once they have completed their 8 month end-of-treatment interview, using semi-structured interviews to explore experiences of the programme and how perceived benefits were achieved, and to identify core and local contextual factors affecting delivery of the programme in an NHS context. This will inform development of guidance to support future scale-up in the event of a positive trial result. Participant interviews will be conducted by a study peer researcher with lived experience of mental health difficulties, who will also lead the analysis. When seeking consent to take part in the study, we will ask all participants if they would like to receive a report of study findings, and will send one to all participants who request this. _____ Previous interventions: This is a researcher-blind, randomised controlled trial with two arms. Staff in participating NHS services will briefly describe the study to potentially eligible service users and refer participants who are interested in taking part and agree to be referred to the study research team. A study researcher will provide an information sheet and discuss the study further with potential participants; then take formal consent from those who wish to take part. All consenting, potential participants will then be screened by researchers for loneliness and meeting treatment resistant depression criteria. Baseline measures will then be completed with those who are eligible, who will then be enrolled in the study and allocated at random to the treatment or the control group. The Trial Manager or administrator will inform the person's GP and care team that they are taking part in the trial, and will inform the participant which trial arm they are allocated to, and will inform the Community Navigators' supervisors of all participants randomized to the intervention arm, who require allocation to a Community Navigator. We aim to recruit 306 service users to take part in the trial, from four NHS sites in London, Birmingham and Yorkshire. We anticipate this recruitment will take 16 months, from June 2022 to September 2023. Each participant receiving the study intervention will receive up to ten 1:1 meetings with a Community Navigator as well as up to four “meet-ups” open to all participants over an 8-month period. The "meet-ups" will run alongside the intervention, facilitated by the Community Navigators. Participants will receive the study intervention in addition to routine care from a specialist community mental health team (CMHT). The control group will receive routine CMHT care plus written information about local social resources. Routine care for both trial groups includes reviews by a psychiatrist and, typically, regular meetings with a care coordinator and where indicated, psychological therapy. Assessments for all participants will be performed by blinded researchers at the time of consent (baseline), 8-month (end of treatment) and 14 month (six months after end of treatment). Baseline measures will be performed at the screening visit. Additional depression and loneliness ratings will be collected through a self-completed online form or through a phone or video call with a study researcher at 4 and 11 months. We will collect qualitative data from selected, consenting participants and intervention providers at two stages: a) Qualitative study 1: during the internal pilot phase, to understand any barriers to trial recruitment and intervention engagement, using an anonymised online survey for all participants who agree to be contacted about this (Qualitative study 1a) and semi-structured interviews with 20 participants from the treatment group (Qualitative study 1b); and b) Qualitative study 2: with 20 intervention group participants later in the trial, once they have completed their 8 month end-of-treatment interview, using semi-structured interviews to explore experiences of the programme and how perceived benefits were achieved, and to identify core and local contextual factors affecting delivery of the programme in an NHS context. This will inform development of guidance to support future scale-up in the event of a positive trial result. Participant interviews will be conducted by a study peer researcher with lived experience of mental health difficulties, who will also lead the analysis. When seeking consent to take part in the study, we will ask all participants if they would like to receive a report of study findings, and will send one to all participants who request this. |
| Intervention type | Other |
| Primary outcome measure | Depression severity (PHQ-9) at 8 months (end-of-treatment) |
| Secondary outcome measures | 1. Depression severity (PHQ-9); Timepoint(s): baseline, 4, 11, and 14 months 2. Number of patients achieving a 20% reduction in PHQ-9; Timepoint(s): Baseline, 8 and 14 months 3. Number of patients who achieve remission of depressive symptoms, defined as a PHQ-9 score of <10; Timepoint(s): Baseline, 8 and 14 months 4. Loneliness (ULS-8); Timepoint(s): Baseline, 4, 8, 11, and 14 months 5. Anxiety (GAD-7); Timepoint(s): Baseline, 8 and 14 months 6. Process of Recovery (QPR); Timepoint(s): Baseline, 8 and 14 months 7. Four-item Multiple Identities Scale (MIS); Timepoint(s): Baseline, 8 and 14 months 8. Brief Rosenberg self-esteem scale (B-RSES); Timepoint(s): Baseline, 8 and 14 months 9. Self-stigma (DISC-12 sub-scale); Timepoint(s): Baseline, 8 and 14 months 10. Lubben Social Network Schedule (LSNS-6); Timepoint(s): Baseline, 8 and 14 months 11. EuroQol EQ-5D 5 level (EQ-5D-5L); Timepoint(s): Baseline, 8 and 14 months 12. Recovering Quality of Life (ReQoL); Timepoint(s): Baseline, 8 and 14 months 13. Client Service Inventory (CSRI); Timepoint(s): Baseline, 8 and 14 months 14. Daytime Activities Questionnaire; Timepoint(s): Baseline, 4, 8, 11, and 14 months |
| Overall study start date | 01/09/2021 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 306; UK Sample Size: 306 |
| Total final enrolment | 314 |
| Key inclusion criteria | 1. Age 18+ years 2. Meet ICD-10 diagnostic criteria for depression assessed using the Clinical Interview Schedule - Revised (CIS-R) interview 3. Have had at least two reported courses of anti-depressants without symptom remission, confirmed by the participant 4. Score of 2 or more on 6-item De Jong Gierveld Loneliness Scale (DJG-6) |
| Key exclusion criteria | Current exclusion criteria as of 28/11/2024: 1. Are due to be discharged from the mental health team within the trial intervention period (8 months) 2. Currently using mental health inpatient services 3. Identified by involved clinicians or clinical records as having a primary diagnosis of a serious mental illness other than TRD, defined as schizophrenia or other non-mood psychotic disorders (ICD-10 codes F20-29 or equivalent) or bipolar disorder (ICD-10 code F31 or equivalent), or a diagnosis of dementia (ICD-10 codes F00-F03 or equivalent) or mild cognitive impairment (ICD-10 code F06.7 or equivalent) 4. Lacks capacity to consent to participate 5. Does not understand English well enough to give informed consent and engage with the study intervention 6. Has a care coordinator who supervises the Community Navigators _____ Previous exclusion criteria: 1. Are due to be discharged from the mental health team within the trial intervention period (8 months) 2. Currently using mental health inpatient services 3. Identified by involved clinicians or clinical records as having a primary diagnosis of a serious mental illness other than TRD, defined as schizophrenia or other non-mood psychotic disorders (ICD codes F20-29) or bipolar disorder (ICD code F31) 4. Lacks capacity to consent to participate 5. Does not understand English well enough to give informed consent and engage with the study intervention 6. Has a care coordinator who supervises the Community Navigators |
| Date of first enrolment | 15/07/2022 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St. Pancras Way
London
NW1 0PE
United Kingdom
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom
St Anns Road
London
N15 3TH
United Kingdom
Hampstead Road
London
NW1 7QY
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Sponsor information
Hospital/treatment centre
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
| Phone | +44 20 7450 8507 |
|---|---|
| sponsor.noclor@nhs.net | |
| Website | http://www.candi.nhs.uk/ |
"ROR" |
https://ror.org/03ekq2173 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 22/03/2022 | 05/07/2022 | No | Yes |
| Protocol file | version 1.0 | 04/02/2022 | 05/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 06/10/2023 | 10/10/2023 | Yes | No |
Additional files
Editorial Notes
28/11/2024: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2025 to 31/12/2025.
2. The interventions were changed.
3. The total final enrolment was added.
4. The exclusion criteria were changed.
5. The study participating centres Central & North West London NHS Foundation Trust Headquarters, North East London NHS Foundation Trust were added.
10/10/2023: Publication reference added.
24/06/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
