Condition category
Mental and Behavioural Disorders
Date applied
12/09/2016
Date assigned
12/10/2016
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Economic recessions are usually characterised by rises in unemployment, debt and increased home repossession. They are also often accompanied by increases in the rate of of suicide and self-harm. Evidence of the impact of the 2008 global economic recession on suicide has been steadily growing, with studies showing that rates of suicide have increased, particularly amongst men and in countries and areas with the highest rises in unemployment. Many countries have responded to the recession with a series of austerity measures and there is population-level evidence of the negative impact of these on health and suicide rates in Europe. Data from an earlier stage of the study team’s National Institute of Heath Research (NIHR) funded research into the impact of the recent recession on self-harm and suicide in England, has highlighted that vulnerable individuals commonly experience difficulties navigating the benefits system and in accessing available sources of welfare and debt advice. This was especially the case for people with pre-existing mental health problems and whose self-harm was precipitated by financial, employment, benefits or housing problems arising from financial difficulties. There is very little information about suitable approaches to help people in this situation. The aim of this study is to conduct a small study looking at the effectiveness of a “navigator”-based program to help these people to navigate the benefits system to access available sources of welfare and debt advice, in order to see if a large scale study would be feasible.

Who can participate?
Adults who have self-armed or present to the hospital emergency department in acute distress in the context of financial, employment, benefits, and housing and associated problems arising from financial difficulties

What does the study involve?
Potentially eligible patients are identified and recruited by members of the liaison psychiatry team at the Bristol Royal Infirmary (BRI). If the patient agrees to contact with the researcher and navigator service, consent is taken by the clinician and patient details are then passed on to the researcher and HOPE Worker. Participants are then randomly allocated to one of two groups. Those in the first group receive one session with a HOPE worker assessing the participant’s economic and mental health needs, checking benefits entitlements and signposting to appropriate services, plus providing relevant written materials. Those in the second group receive up to six hour-long sessions with a HOPE worker assessing the participant’s economic and mental health needs, checking benefit entitlements and guiding and signposting to appropriate services. Maintaining contact with the participant, making telephone calls, opening correspondence, and attending appointments with the participant if necessary to ensure attendance. The HOPE worker provides practical support and use motivational interviewing techniques (a method which works on helping and encouraging a person to become motivated to change behaviour) in their work with the client. The aim of the service is to support clients through a period of acute distress to a level where the situation initiating their self-harm is resolved. At the end of the study, the number of participants who took part are recorded to find out if a larger study would be feasible.

What are the possible benefits and risks of participating?
Participants distressed due to financial difficulties (but not reaching the criteria for secondary mental health care) will be receiving a navigator service to help them access support that is not currently on offer. No matter which group they are allocated to they will benefit from receiving guidance and support to help them move out of the crisis that precipitated their hospital admission. The aim of the intervention is not just to move people on from their situation but to help them feel more confident about managing future financial, employment or benefit difficulties. Participants may not be happy about being allocated to the no-treatment group and not the enhanced service. To address this, people in this group will still be offered a signposting session; a service not currently available to people in their situation. Participants who receive the enhanced navigator service may find the support too intrusive and/or inconvenient. Participants will be reminded at every session that participation is entirely voluntary and they are able to withdraw at any point without prejudicing further treatment (outside of the study). The follow-up interview may cause distress by asking questions about the participants’ current or past situation. The research team has considerable experience of interviewing suicidal/distressed individuals have procedures to safeguard patient well-being
Where is the study run from?
Bristol Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
April 2015 to September 2017

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

Who is the main contact?
1. Dr Maria Barnes (scientific)
maria.barnes@bristol.ac.uk
2. Professor David Gunnell (scientific)
d.j.gunnell@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Barnes

ORCID ID

Contact details

University of Bristol
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 117 9287253
maria.barnes@bristol.ac.uk

Type

Scientific

Additional contact

Prof David Gunnell

ORCID ID

http://orcid.org/0000-0002-0829-6470

Contact details

School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 117 004 4117
d.j.gunnell@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31149

Study information

Scientific title

A practical support intervention (HOPE) for people presenting to the hospital emergency department in mental health crisis / following self-harm where financial, employment, welfare benefit and housing problems contributed to their crisis: pilot randomised controlled trial

Acronym

HOPE

Study hypothesis

The aim of this study is to investigate the feasibility of recruiting and randomising participants and collecting outcomes for a study looking at a “navigator”-based intervention for people who have self-harmed or present to the hospital emergency department in acute distress in the context of financial, employment, benefits, housing and associated problems arising from financial difficulties.

Ethics approval

South West - Central Bristol Research Ethics Committee, 12/04/2016, ref: 16/SW/0005

Study design

Randomised; Interventional; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

-

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment rate over the 9 month pilot as recorded as the proportion of people consenting and number of people being referred to the researcher for recruitment and randomisation
2. Acceptability of the intervention, randomisation and questionnaire based measures to be recorded through qualitative interviews with participants
3. Loss to follow-up at 3 months recorded as proportion of people not partaking in the full intervention
4. Identification of additional training needs of navigators through on-going training and qualitative interviews

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/04/2015

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. People who have self ­harmed, or expressed suicidal thoughts or are in mental health crisis but do not meet the criteria for referral to secondary mental health care but who, without intervention, would probably suffer further deterioration in their mental health and risk of suicide
2. Those whose psychosocial assessment indicates that job loss, difficulties finding a job, benefit changes and/or sanctions (actual or fear of changes and sanctions), debt and economic hardship or housing problems as a result of financial problems were a key contributory factor to their self harm
3. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. Referred for secondary care psychiatric community or inpatient services by the hospital liaison psychiatry team
2. Experiencing a psychotic episode or are thought­disordered or unable to give consent
3. Patients with alcohol misuse problems
4. Aged below 18 years
5. Not fluent in English (as funding for the pilot navigator team is currently insufficient to provide people with different language skills / translators) or who would struggle with filling in forms or being interviewed
6. Living outside of the catchment area for the service

Recruitment start date

16/05/2016

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Liaison Psychiatry A214 Clinic Queens Building Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research & Enterprise Development (RED)
Senate House
level 3
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

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

There will be two papers submitted to peer-reviewed journals:
1. The protocol of the study to be submitted by year end
2. The results from the study to be submitted by end 2017

Intention to publish date

31/07/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes