Condition category
Mental and Behavioural Disorders
Date applied
03/04/2017
Date assigned
07/04/2017
Last edited
25/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with mental health problems are often vulnerable to loneliness, which affects their quality of life and can impede recovery. Loneliness can be defined as a negative experience arising due to the difference between someone’s desired and achieved quantity and/or quality of social relationships. Loneliness has been associated with many negative health outcomes in the general population such as shorter life expectancy. It also predicts the onset of anxiety and depression, and leads to worse outcomes for those who are anxious or depressed. In addition, people with mental health problems are often particularly vulnerable to loneliness. The aim of this study is to develop and test a programme of support to increase community connections and reduce loneliness for people with complex anxiety or depression.

Who can participate?
Adults who are using participating mental health services who are feeling lonely.

What does the study involve?
After agreeing to take part in the study, participants complete some questionnaires assessing their social relationships, quality of life and mental health. They are then randomly allocated to one of two groups. Those in the first group receive standard care from their clinical teams and are also offered a pack of written information about community resources and activities within their area. Those in the second group receive a programme of support from a ‘Community Navigator’. This involves 10 meetings with the Community Navigator over six months, to help people review their current relationships, activities and interests and make a plan with the aim of reducing loneliness. There is a budget of £100 per person available to help put these plans into action. Participants receiving support from a Community Navigator are also invited to attend up to three group meetings, which provide opportunities to meet other participants, discuss the programme and their progress, and share resources and experiences. After six months, all participants are asked to complete the same questionnaires as at the start. In-depth feedback is also collected through interviews with 20 of the participants receiving support from a Community Navigator, the Community Navigators themselves, and 10 other involved people.

What are the possible benefits and risks of participating?
Support from a Community Navigator may reduce people’s 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. Participants will be involved in a study which will help to find out more about what kind of support is helpful for people with anxiety or depression who are experiencing feelings of loneliness. It is possible that participants will not find receiving support from the Community Navigator or the written information about local resources helpful and this could be disappointing. Working to increase their community connections may be difficult for participants. They will remain under the care of NHS clinical services and receiving standard care throughout the programme, so expert help and support with any distress will be available. It is possible that people may be disappointed when their meetings with a Community Navigator end after 10 sessions.

Where is the study run from?
1. Complex Depression, Anxiety and Trauma Service, St Pancras Hospital (UK)
2. Barnet Complex Care Team, Edgware Community Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2016 to February 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Brynmor Lloyd-Evans
b.lloyd-evans@ucl.ac.uk

Trial website

https://www.ucl.ac.uk/psychiatry/research/epidemiology/community-navigator-study/

Contact information

Type

Scientific

Primary contact

Dr Brynmor Lloyd-Evans

ORCID ID

http://orcid.org/0000-0001-9866-788X

Contact details

Division of Psychiatry
University College London
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 20 7679 9428
b.lloyd-evans@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31617

Study information

Scientific title

Feasibility trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression

Acronym

Study hypothesis

The aim of this study is to develop and test the feasibility and acceptability of a programme of support for people with significant depression or anxiety who use specialist mental health services. This programme of support will include receiving support from a ‘Community Navigator’, who will work with the participating service users to increase their social activities and community engagement, with the aim of reducing feelings of loneliness or social isolation. This support will be in addition to treatment as usual from a secondary mental health service.

Ethics approval

East of England - Cambridge Central Research Ethics Committee, 26/07/2016, ref: 16/EE/0255

Study design

Randomised; Both; Design type: Treatment, Psychological & Behavioural, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Mental Health, Primary sub-specialty: Study not assigned to a MH Clinical Studies Group; UKCRC code/ Disease: Mental Health/ Unspecified mental disorder

Intervention

Participants are randomised to one of two groups. Randomisation will be conducted by an independent statistician in the UCL Division of Psychiatry, who is not connected to the study team. Allocation of participants in the feasibility trial (n=40) will be by block randomisation, stratified by study site. There will be unequal allocation between treatment arms, with 30 participants in the treatment group and 10 in a control group. Due to limitations in the researcher resources available, participants’ allocations will not be concealed from the research team.

Intervention arm: Participants will be offered 10 meetings with a Community Navigator over a six-month period with the aim of increasing community connections and reducing loneliness. Each participant may access a budget of up to £100 on goals agreed with their Community Navigator to facilitate access to and participation in social activity, and to develop network connections. The intervention comprises three main components:
1. A thorough review of each participant’s existing social network, and the current and potential support it provides; the person’s existing strengths and interests; potential areas where new activity, social connection or support would be of interest; and any current barriers to pursuing these
2. Support to develop and use an action plan to increase connectedness. This will be person centred and include: providing information about available activities and sources of support locally; practical help to access activity; access to financial support from a budget; emotional support to overcome barriers to increasing social connectedness
3. Participants will be invited to attend up to three meetings for all participants which provide opportunities to meet co-participants, discuss the programme’s aims and progress, and share information about helpful local resources and experiences

Control arm: Participants will receive treatment as usual and will be offered a pack of written information about community resources and activities within their area.


The total duration of treatment and follow-up will be six months from baseline.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility measures:
1. Recruitment duration is recorded as the time period from recruitment of the first trial participant to meeting the trial recruitment target (40 participants)
2. Recruitment rate is recorded as the number of participants screened, the number of those screened who are eligible, and the number of eligible participants who consent to participate in the study by four months
3. Attrition rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at six months
4. Number of adverse events recorded in each study arm until the end of follow up at six months
5. Intervention take-up rate for those in the intervention arm, where the minimum threshold for intervention take-up is three sessions with a Community Navigator
6. Implementation of the intervention is recorded as the proportion of participants that maintained engagement with a Community Navigator and the number of sessions of support provided
7. Process evaluation is undertaken through qualitative interviews at the end of treatment with treatment group participants, Community Navigators and other stakeholders as well as Community Navigators’ records of sessions and feedback from treatment group participants after two of their sessions with a Community Navigator

Secondary outcome measures

Potential primary and secondary outcomes for a future definitive RCT are being measured to assess acceptability, response and completeness:
1. Loneliness is measured using the de Jong Gierveld loneliness scale (11 items) at baseline and six months
2. Depression severity is measured using the Patient Health Questionnaire (PHQ-9) at baseline and six months
3. Anxiety severity is measured using the Generalized Anxiety Disorder Questionnaire (GAD-7) at baseline and six months
4. Social network is assessed with the abbreviated Lubben Social Network Scale (LSNS-6) at baseline and six months
5. Social capital is measured with the Resource Generator UK (RG-UK) at baseline and six months
6. Activity over the previous week is measured using the Time Budget Diary, with additional questions on whether activities were done with others or alone and, if with others, whether this was online or face-to-face at baseline and six months
7. Wellbeing is measured with the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and six months
8. Health-related quality of life is measured with the EQ-5D-5L at baseline and six months
9. Mental health-related quality of life is assessed on the Recovering Quality of Life Questionnaire brief version (ReQoL-10) at baseline and six months
10. Information is sought from Trust Informatics teams regarding participants’ current diagnosis, care cluster, attended and missed face-to-face appointments with their clinical team, use of other community mental health services, admission to acute care, days in inpatient care over previous six months, and use of the Mental Health Act. These records are sought for the six months prior to baseline and at six month follow up for the intervention period since baseline.
11. Records of participants’ use of social care services are sought for the six months prior to baseline and at six month follow up for the intervention period since baseline

Overall trial start date

01/03/2016

Overall trial end date

28/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Current male and female service users of participating services (Camden and Islington Complex Depression Anxiety and Trauma Team or the Mood Anxiety and Personality Stream of the Barnet Complex Care Team)
2. Aged 18 or over (there is no upper age limit for this study)
3. Service users currently receiving multi-disciplinary support (e.g. care co-ordination and medical input, and access to psychology support) will be prioritised to help explore whether community navigation support is a useful addition within these services

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 participants in the trial, plus an additional 13 participants involved in qualitative interviews

Participant exclusion criteria

1. Lacks capacity to consent to participate;
2. Poses a risk of harm to others such that meetings with a researcher or community navigator are not advised by staff from participating clinical services;
3. Is unable to communicate in English;
4. Is currently an inpatient at a mental health or general hospital;
5. Do not meet a threshold level for loneliness on a brief screening questionnaire.

Recruitment start date

20/04/2017

Recruitment end date

31/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Complex Depression, Anxiety and Trauma Service
Camley Building St Pancras Hospital 4 St Pancras Way
London
NW1 0PE
United Kingdom

Trial participating centre

Barnet Complex Care Team
Dennis Scott Unit Edgware Community Hospital Burnt Oak Broadway
Edgware
HA8 0AD
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
Gower Street
London
WC1E 6BT
United Kingdom
+44 20 3447 5557
randd@uclh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The funders require, within 30 days of the end of the study, an End of Project Report, and a brief, accessible “Findings” document. Publication in a high-impact peer reviewed journal is also planned, with intent to publish by February 2019. Planned publication of the trial protocol in a peer-reviewed journal before the end of participant recruitment.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Brynmor Lloyd-Evans (b.lloyd-evans@ucl.ac.uk).

Intention to publish date

28/02/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29061185

Publication citations

Additional files

Editorial Notes

25/10/2017: Publication reference added.