VIP (Victim Improvement Package) Trial: helping older victims of crime with chronic symptoms of depression and or anxiety using a therapist delivered victim improvement package

ISRCTN	ISRCTN16929670
DOI	https://doi.org/10.1186/ISRCTN16929670
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NIHR-PHR Project:13/164/32
Sponsor	University College London
Funder	National Institute for Health Research

Submission date: 19/02/2016
Registration date: 03/08/2016
Last edited: 28/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 directing 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 the 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 February 2024

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

Who is the main contact?
Dr Marc Sertaty, m.serfaty@ucl.ac.uk

Contact information

Dr Marc Serfaty
Scientific

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

Phone	+44 20 7679 9712
Email	m.serfaty@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Assessor-blinded randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	VIP
Study objectives	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(s)	UCL Research Ethics Committee, 17/03/2016, ref: 6960/001
Health condition(s) or problem(s) studied	Depression and anxiety in older victims of crime
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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	29/02/2024

Eligibility

Participant type(s)	Other
Age group	Senior
Lower age limit	65 Years
Sex	All
Target sample size at registration	226
Total final enrolment	131
Key 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
Key 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)
Date of first enrolment	01/02/2017
Date of final enrolment	02/08/2022

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/07/2025	28/07/2025	Yes	No
Protocol article	protocol	16/04/2020	20/04/2020	Yes	No
Other publications	Cross-agency working when conducting a pragmatic RCT for older victims of crime: our experiences and lessons learned	15/01/2025	20/01/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/07/2025: Publication reference added.
20/01/2025: Publication reference added.
19/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 02/08/2022.
2. The overall end date was changed from 31/08/2024 to 29/02/2024.
3. The plain English summary was updated to reflect these changes.
4. Total final enrolment added.
01/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 17/03/2023 to 30/09/2023.
2. The overall end date was changed from 31/08/2023 to 31/08/2024.
3. The plain English summary was updated to reflect these changes.
06/04/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2022 to 31/08/2023.
2. The recruitment end date was changed from 30/04/2022 to 17/03/2023.
3. The plain English summary was updated to reflect these changes.
4. The intention to publish date was changed from 30/04/2023 to 30/08/2024.
20/04/2021: The recruitment end date was changed from 30/04/2021 to 30/04/2022.
09/07/2020: The trial contact details have been made publicly visible.
20/04/2020: Publication reference added.
16/03/2020: Internal review.
22/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2019 to 30/04/2021.
2. The overall end date was changed from 31/01/2020 to 30/04/2022.
3. The intention to publish date was changed from 30/04/2018 to 30/04/2023.
4. The plain English summary was updated to reflect these changes.
28/05/2019: Internal review.