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 |
| Secondary identifying numbers | NIHR-PHR Project:13/164/32 |
- Submission date
- 19/02/2016
- Registration date
- 03/08/2016
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
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 |
|---|---|
| m.serfaty@ucl.ac.uk |
Study information
| Study design | Assessor-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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 study start date | 01/04/2014 |
| Completion date | 29/02/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
Sponsor information
University/education
Joint Research Office (part of the Research Support Centre)
1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
| Phone | +44 203 447 5199 |
|---|---|
| david.wilson@ucl.ac.uk | |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. Websites 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. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 |
Editorial Notes
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.
