Condition category
Mental and Behavioural Disorders
Date applied
02/12/2019
Date assigned
30/01/2020
Last edited
15/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Sexual assault referral centres (SARCs) are specialised services for the treatment of people who have experienced sexual assault. SARCs may deliver psychological and emotional support or refer or signpost people to other organisations in the local area. Mental ill health and substance use are common among people who attend SARCs. For example,about 2 in 5 SARCs attendees are estimated to have a mental health problem. Despite this, there is limited evidence regarding the mental health and substance use needs of people who attend SARCs, what works for which people in which context and where resources could be best allocated to provide the most benefit.
This study is part of a wider project exploring how well SARCs help people in terms of mental health and substance use. The study aims to identify how many people attending SARCs have a substance use or mental health difficulty, what services and referral pathways are provided by SARCs, and to explore the attendees' satisfaction with care, barriers to access and gaps in provision, as well as comparing different forms of mental health treatment received following a sexual assault.

Who can participate?
Adults who attend a SARC who can understand English or who have suitable translation services available. For those who participate in the interview in the second part of the study, they need to have a mental health or substance use need.

What does the study involve?
The researchers have identified 6 SARCS that will be used to undertake the following activities. The first is a survey of SARC attendees, with questionnaires of mental health, substance use and quality of life at two times - shortly after SARC attendance and again 6 months later. The second activity involves case studies of the 6 SARCS, including interviews and focus groups with service users, SARC staff and other stakeholders. This also includes an analysis of SARC documentation (e.g. policies, protocols) related to mental health and substance use provision. The third activity will follow up on the health outcomes of people who receive different types of psychological treatment from either a SARC or a mental health service.

What are the possible benefits and risks of participating?
The study itself will not necessarily help participants, but the information that they provide will help increase the understanding of how SARCs can improve mental health treatment for people after sexual assault. Participants will be able to have their views of the services they received heard and recognised, which may provide a 'therapeutic' benefit associated with 'having a voice'. All participants will receive information about sources of help and support.
The research team will ask participants questions about their mental health symptoms and the care that they have received, which they may find personal or distressing. Participants can take time in answering and do not have to answer questions that they do not want to. They can discuss any concerns with the researcher at any point and we will ask if they would like their GP told, so that the GP can provide further support.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
June 2018 to December 2021

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

Who is the main contact?
Dr Rebekah Shallcross, r.shallcross@leeds.ac.uk

Trial website

http://mimosstudy.org.uk

Contact information

Type

Scientific

Primary contact

Dr Rebekah Shallcross

ORCID ID

http://orcid.org/0000-0003-4764-0411

Contact details

Baines Wing
School of Healthcare
University of Leeds
13 Beech Grove Terrace
Leeds
LS2 9DA
United Kingdom
+44 (0)113 343 0963
r.shallcross@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 43811, IRAS 238240

Study information

Scientific title

The effectiveness of sexual assault referral centres with regard to mental health and substance use: a national mixed-method study

Acronym

MiMoS

Study hypothesis

Sexual assault referral centres (SARCs) are specialised services for the treatment of people who have experienced sexual assault. In recognition of the psychological impact of sexual assault, SARCs may deliver psychological and emotional support or refer/signpost to other agencies in the local area. Mental ill health and substance use are common among people who attend SARCs. For example, approximately 40% of SARCs attendees are estimated to have a mental health problem. Despite this, there is limited evidence regarding the mental health and substance use needs of people who attend SARCs, what works for whom in what context and where resources could be best allocated to obtain maximum benefit.

This study is part of a wider mixed-methods project exploring the effectiveness of SARCs for mental health and substance use. The study aims to identify how many people attending SARCs have a substance use or mental health difficulty, what services and referral pathways are provided by SARCs, and to explore satisfaction with care, barriers to access and gaps in provision, as well as comparing different forms of mental health treatment received following a sexual assault.

Ethics approval

Approved 06/12/2019, North West - Preston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ; +44 (0)207 104 8197; nrescommittee.northwest-preston@nhs.net), ref: 19/NW/0663

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Mental and behavioural disorders and psychoactive substance use in people who attend sexual assault referral centres (SARCs)

Intervention

The researchers have identified 6 SARCS who they will recruit from to undertake the following activities:
1. A survey of SARC attendees with questionnaires of mental health, substance use and quality of life at two timepoints: shortly after SARC attendance and again 6 months later
2. Case studies of 6 SARCs, including interviews and focus groups with service users, SARC staff and other stakeholders, and an analysis of SARC documentation (e.g. policies, protocols) related to mental health and substance use provision
3. A historical cohort study of the clinical outcomes of people who receive different models of psychological treatment from either a SARC or a mental health service

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Survey:
Mental health assessed using the Mental Health Symptoms CORE-10 at baseline and 6-month follow-up

Cohort study:
Symptoms of mental health disorder measured using the CORE-OM (a 34-item self-report questionnaire of psychological distress over the last week) at ???

Secondary outcome measures

Survey:
1. Alcohol use assessed using AUDIT-C at baseline and 6-month follow-up
2. Post-traumatic stress disorder (PTSD) symptoms assessed using the primary care PTSD screen for DSM-5 (PC-PTSD-5) at baseline and 6-month follow-up
3. Quality of life assessed using the ReQoL scale at baseline and 6-month follow-up
4. Drug use assessed using the Drug Abuse Screening Test (DAST) at baseline and 6-month follow-up
5. Personality traits assessed using the Standardised Assessment of Personality: Abbreviated Scale (SAPAS) at baseline
6. Proportion of different mental health, substance misuse and counselling services used by people in contact with SARCs assessed using an adapted version of the Service Receipt Inventory at 6-month follow-up
7. Participant’s satisfaction and perceptions of unmet need assessed using an adapted version of the Service Receipt Inventory at 6-month follow-up

Overall trial start date

01/06/2018

Overall trial end date

01/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

The current study aims to be as inclusive as possible for this research. For that reason, for WP3 and 4 the researchers have kept the inclusion criteria broad and have limited the exclusion criteria:

Inclusion:
1. Aged 18 or over
2. Can read and understand English or there are suitable confidential translation services available
3. Have identified a mental health or substance use need to take part in the interview

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 432; UK Sample Size: 432

Participant exclusion criteria

1. Lacks capacity to provide informed consent
2. Where participation is deemed to significantly increase risk to self or others
3. SARC attendee, significant other of attendee, or staff of a SARC not participating in the study

Recruitment start date

10/02/2020

Recruitment end date

01/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford RD
Manchester
M13 9WL
United Kingdom

Trial participating centre

Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

G4S Health Services
Swift House 18 Hoffmanns Way
Chelmsford
CM1 1GU
United Kingdom

Trial participating centre

Mountain Healthcare
The Mount The Green
Finchingfield
CM7 4JX
United Kingdom

Trial participating centre

Kent and Medway NHS and Social Care Partnership Trust
Farm Villa Hermitage Lane
Maidstone
ME16 9PH
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Maudsley Hospital Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

Faculty NHS Research Ethics Officer
Faculty Research Office
Room 9.29
Level 9
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
+44 (0)113 343 7587
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

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

Results will be reported in peer-reviewed journals and conference presentations. There will also be an internal report and information provided on a website.

IPD sharing statement:
Non-identifiable research data will be made publicly available with written consent from participants on the University of Leeds repository (or other data repository as guided by journal publishers), with relevant data sharing agreements in place.

Intention to publish date

01/12/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/04/2020: Due to current public health guidance, recruitment for this study has been paused.