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Published in: Trials 1/2020

Open Access 01-12-2020 | Affective Disorder | Study protocol

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 (the VIP trial): study protocol for a randomised controlled trial

Authors: Marc Serfaty, Trefor Aspden, Jessica Satchell, Anthony Kessel, Gloria Laycock, Chris R. Brewin, Marta Buszewicz, Aidan O’Keeffe, Rachael Hunter, Gerard Leavey, Jon Cuming-Higgs, Vari Drennan, Monica Riveros, David Andrew, Martin Blanchard

Published in: Trials | Issue 1/2020

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Abstract

Background

Older people are vulnerable to sustained high levels of psychosocial distress following a crime. A cognitive behavioural therapy (CBT)-informed psychological therapy, the Victim Improvement Package (VIP) may aid recovery. The VIP trial aims to test the clinical and cost-effectiveness of the VIP for alleviating depressive and anxiety symptoms in older victims of crime.

Methods/design

People aged 65 years or more who report being a victim of crime will be screened by Metropolitan Police Service Safer Neighbourhood Teams within a month of the crime for distress using the Patient Health Questionnaire-2 and the Generalised Anxiety Disorder-2. Those who screen positive will be signposted to their GP for assistance, and re-screened at 3 months. Participants who screen positive for depression and/or anxiety at re-screening are randomised to a CBT informed VIP added to treatment as usual (TAU) compared to TAU alone. The intervention consists of 10 individual 1-h sessions, delivered weekly by therapists from the mental health charity Mind.
The primary outcome measure is the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI), used as a composite measure, assessed at 6 months after the crime (post therapy) with a 9-month post-crime follow-up. Secondary outcome measures include the EQ-5D, and a modified Client Service Receipt Inventory. A total of 226 participants will be randomised VIP:TAU with a ratio 1:1, in order to detect a standardised difference of at least 0.5 between groups, using a mixed-effects linear-regression model with 90% power and a 5% significance level (adjusting for therapist clustering and potential drop-out).
A cost-effectiveness analysis will incorporate intervention costs to compare overall health care costs and quality of life years between treatment arms. An embedded study will examine the impact of past trauma and engagement in safety behaviours and distress on the main outcomes.

Discussion

This trial should provide data on the clinical and cost-effectiveness of a CBT-informed psychological therapy for older victims of crime with anxiety and/or depressive symptoms and should demonstrate a model of integrated cross-agency working. Our findings should provide evidence for policy-makers, commissioners and clinicians responding to the needs of older victims of crime.

Trial registration

International Standard Randomised Controlled Trials Number, ID: ISRCTN16929670. Registered on 3 August 2016.
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Metadata
Title
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 (the VIP trial): study protocol for a randomised controlled trial
Authors
Marc Serfaty
Trefor Aspden
Jessica Satchell
Anthony Kessel
Gloria Laycock
Chris R. Brewin
Marta Buszewicz
Aidan O’Keeffe
Rachael Hunter
Gerard Leavey
Jon Cuming-Higgs
Vari Drennan
Monica Riveros
David Andrew
Martin Blanchard
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4211-9

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