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 (0)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 (0)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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29043091
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30459961