Condition category
Mental and Behavioural Disorders
Date applied
19/02/2016
Date assigned
03/08/2016
Last edited
03/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Being the victim of common crime can affect people deeply, with many going on to develop mental health issues such as depression and anxiety. The social and physical problems associated with old age increase vulnerability, meaning that older victims are twice as likely to die or require residential care, than people of the same age who have not been a victim of crime. Since 85% of depressed older people do not receive any specific treatment, this lack of care is also likely to apply to older victims of crime. Metropolitan Police reports suggest that over 26,000 common crimes were committed against older people in seven London boroughs between 2009 and 2010. In a previous study (Helping Aged Victims of Crime (HAVoC) study), older victims of crime were surveyed and it was found that a high proportion were suffering from anxiety and/or depression, which continued long after the crime took place. This led to the development of a Victim Improvement Package (VIP) for treating this type of distress. The aim of this study is to investigate the effectiveness of the VIP. This involves identifying older victims within a month of a crime who have significant psychological distress and direct them to sources of help, then to see if they have accessed any help and those who still have significant distress at 3 months after the crime are offered the opportunity to take part in a trial to see if we can prevent ongoing symptoms using a victim improvement package.

Who can participate?
Victims of reported common serious crime aged 65 years or more, living in selected London boroughs, with depression and/or anxiety.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive treatment as usual for the duration of the study. Those in the second group receive treatment as usual, but also take part in the victim improvement package (VIP). The VIP package consists of up to 10 sessions of CBT which will involve talking about the crime that participant experienced, being asked to keep a mood diary to identify unhelpful thoughts and behaviour related to the crime and then tackling them so that they no longer cause distress. All participants complete a number of questionnaires three months after the crime (baseline) and then six and nine months after the crime to measure anxiety/depression levels.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
April 2014 to January 2020

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

Who is the main contact?
Dr Marc Sertaty

Trial website

www.ucl.ac.uk/Victim-Imrpovement-Package-Trial

Contact information

Type

Scientific

Primary contact

Dr Marc Serfaty

ORCID ID

Contact details

Department of Epidemiology and Applied Clinical Research
Division of Psychiatry
University College London
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF.
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR-PHR Project:13/164/32

Study information

Scientific title

The VIP trial: a randomised controlled trial of the clinical and cost effectiveness of a Victim Improvement Package (VIP) for the reduction of chronic symptoms of depression or anxiety in older victims of common crime

Acronym

VIP trial

Study hypothesis

A Victim Improvement Package plus treatment as usual is more clinically and cost effective at preventing chronicity of symptoms, of depression and/or anxiety, than treatment as usual in victims of common crime, aged 65 years or more.

Ethics approval

UCL Research Ethics Committee, 17/03/2016, ref: 6960/001

Study design

Assessor-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

1. Depression
2. Anxiety

Intervention

Three months post crime, a web-based randomisation by an independent clinical trials unit will allocate participants to either Treatment as Usual (TAU) or TAU plus up to 10 sessions of a CBT informed Victim Improvement Package, delivered over 3 months.

Control group: Participants continue to receive treatment as usual (TAU) alone of the duraction of the study.

Intervention group: Participants receive the victim improvement package (VIP) in addition to treatment as usual. The VIP will consist of up to 10 manualised, individual sessions of modified CBT, delivered over 3 months in community based Mind facilities using a VIP manual. The VIP, tailored to the main presenting symptoms and used flexibly, will cover:
Session 1: A narrative of the crime, underlying beliefs, behaviours and how these have changed
Session 2: Psycho-education about crime and an introduction to CBT
Sessions 3-8: Mood diaries to identify unhelpful thinking and behaviours; guided discovery to challenge beliefs about crime, personal vulnerability and safety; behavioural experiments to challenge unhealthy avoidance
Sessions 9-10: Relapse prevention

Participants will be assessed at 6 months (post intervention) and 9 months (follow-up) post crime.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Depression is measured using the Beck Depression Inventory-II (BDI-II) at baseline (3 months post crime), 6 and 9 months post-crime
2. Anxiety is measured using the Beck Anxiety Inventory (BAI) at baseline (3 months post crime), 6 and 9 months post-crime

Secondary outcome measures

1. Presence of a diagnosis of depression and/ or anxiety is measured at baseline (3 months post crime), 6 months post-crime (post intervention)
2. Social functioning is measured using the Euroqol 5-D at baseline (3 months post crime), and post intervention and followup (6 and 9 months post-crime) respectively
3. Economic measures are collected using a modified Client Services Receipt Inventory (CSRI) will be collected at baseline (3 months post crime), and post intervention and followup (6 and 9 months post-crime) respectively

Overall trial start date

01/04/2014

Overall trial end date

31/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years and over
2. Living in participating London boroughs
3. A MINI (Sheehan et al., 1998) DSM-IV diagnosis of depression (with or without anxiety) or anxiety attributed to the crime

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

226

Participant exclusion criteria

1. MINI diagnosis of schizophrenia, bipolar disorder and/or alcohol or drug dependency
2. Receipt of CBT in the last 6 months
3. Inability to participate in CBT because of language difficulties and/or Mini Mental State Score of <24 (significant cognitive impairment)

Recruitment start date

01/02/2017

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
6th Floor Maple House 149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office (part of the Research Support Centre)
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

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

Findings will be distributed to key partners/stakeholders efficiently and expeditiously, maximising impact by informing local and national service planning and health policy making. A working group of key partners attached to the TSC will work on a definitive national dissemination strategy:

1. Involvement of Public Health England (PHE): The mental health team within PHE’s Health and Wellbeing Directorate will guide around modes of presentation of findings on a national basis (e.g. national workshop, web-formats, stakeholder distribution); the Association of Directors of Public Health (and through the ADPH to local directors of public health and council -based Health and Wellbeing Boards) will be used to ensure effective promulgation of findings locally.
2. Public Organisations: Public Health, the NHS, the Ministry of Justice department, PHE, the NHS/Clinical Commissioning groups; the Ministry of Justice and the Police
3. Conferences: Public organisations: PHE, the Police Federation. Charit ies: national and local Mind, Age UK, Victim Support. Medical conferences: Coordinated through the Royal Colleges; Psychiatry, GPs. Associations: BPS, BABCP, the New Savoy Partnership, APA. Providers of healthcare: R&D departments or clinical commissioning groups.
4. Journals: Reporting will adhere to CONSORT guidelines (http://www.consort -statement.org/), aim for high ranking national and international peer-reviewed journals: public health, primary care, psychology, psychiatry, criminology, including free UK publications to GPs, the BABCP and the Police Federation.
5. Clinicians: Co-applicants have links with Royal Colleges of GPs and Psychiatrists and the BABCP and the IAPT community.
6. NICE: Feedback to NICE could ensure updated guidelines on the management of Depression and Anxiety which are associated with crime.
7. Service users: Service users will advise on the best way to circulate results to users and including Mind, Anxiety UK and Depression Alliance
8. Public: Campaigning to raise awareness of the impact of crime in older people encouraging those with symptoms to come forward for effective treatment. This will involve UCLs press office which connects with a variety of bodies, promoting research and teaching globally.
9. Web-sites linked to: UCL, relevant service user organisations, PHE, NHS Choices (http://www.nhs.uk/News/Pages/NewsIndex.aspx) and Patients like Me (http://www.patientslikeme.com) and the NIHR-PHR.

Intention to publish date

30/04/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes