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
Funder: Department of Health and Social Care

Abstract: Research question: for victims of common crime, aged 65 years or more, does the addition of a Victim Improvement Package (VIP) to treatment as usual (TAU), which includes screening and signposting, reduce significant chronicity of depressive and/or anxiety symptoms compared to TAU alone? Methods: Design: a 3 step process; step 1: screening and signposting; step 2: rescreening and diagnosis; step 3: a parallel, assessor blind randomised controlled trial. Setting: Residents of 7 London boroughs, screened for depression and/or anxiety(1,2) by Metropolitan Police Safer Neighbourhood Teams (SNTs) within 1 month of reported crime and signposted where relevant. Potential cases will be re-screened at 3 months post crime to determine trial eligibility. Participant eligibility for RCT: Inclusion criteria: Victims of crime, 65 years or more, with a DSM-IV diagnosis of depression (with or without anxiety) or anxiety on the MINI(3). Exclusion: criteria: pre-existing mental illness; current alcohol/drug dependency; recent receipt of Cognitive Behaviour Therapy (CBT); inability to communicate in English; significant memory impairment indicated by Mini Mental State Examination. The intervention being evaluated: A cross-service collaborative approach to identify, assess and refer participants for computerised randomisation, stratified by diagnosis, by an independent CTU, to either the VIP (plus TAU) or TAU alone. I. The intervention: The VIP (added to TAU) consists of: up to 10 sessions of a developed and tested manualised individual therapy informed from CBT, delivered, over 3 months. Delivery: Mind CBT therapists in a non NHS setting. Source of funding: HTA PHR for the research and Mind for the therapists. II. The comparator: TAU, which includes screening and signposting, consists of routine support, referral to voluntary agencies, the GP, rarely Stress Disorder Clinics or Improving Access to Psychological Therapies. Many older people are reluctant to take psychotropics, but for ethical reasons these will not be discouraged. Assessment of 1 in 10 audio recordings of therapy sessions will enable (i)assessment of quality of therapy using the Cognitive Therapy Scale-Revised(4) (ii)adherence to the VIP manual. Measurement of outcomes and costs: we will record: demographic and clinical information; type of crime and context; data on vulnerability factors e.g. recent life events, participants’ view of available support. Primary: the Beck Depression Inventory-II (BDI-II;6) and Beck Anxiety Inventory (BAI;7) for those diagnosed with depression and anxiety respectively. Secondary: DSM-IV caseness(3); the EuroQol(8) a generic utility measure of quality of life. Mixed methods to explore signposting (i) Quantitative: if and how people have acted on the signposting. (ii) Qualitative: semi-structured interviews. Economic: a modified version of the Client Service Receipt Inventory(9) to collect economic data. Sources of bias: measures of: attrition and engagement with therapy: drop outs, illness, death, did not attend rates; potential systematic biases: participants’ group preference, belief in the treatment, assessment of “blindness”; prescribed psychotropic medication; other psychological treatments received; measures of fidelity to treatment; measures of satisfaction for the treatment. Researchers will collect data: 3 months post crime (baseline); 6 months post crime (primary endpoint/post-intervention); 9 months post crime (followup)

Lay abstract: The VIP (Victim Improvement Package) study assesses how different agencies, working together, can help older victims of crime by preventing distressing psychological symptoms from continuing. Background: Common crime may affect victims deeply, in some triggering mental illness. Social and physical problems associated with old age increase vulnerability. Furthermore, older victims are twice as likely to die or require residential care, than non-victimised people of the same age. Since 85% of depressed older people do not receive any specific treatment, this lack of care is also likely to apply to older victims. Metropolitan Police reports suggest that over 26,000 common crimes were committed against older people in 7 London boroughs between 2009-10. Previous work: in our Helping Aged Victims of Crime (HAVoC) study, 581 older victims responded to a written survey within a month of a crime. We also asked officers from Metropolitan Police Safer Neighbourhood Teams (SNTs) to approach victims face to face; over 90% of victims agreed to answer questions about psychological distress. At 3 months after the crime, 65% reported their daily life continued to be affected, 27% were psychologically distressed and of these, almost 50% had a psychiatric illness which they felt was caused by the crime. Of these, 26 agreed to be allocated, by a process called randomisation (which is necessary to balance out other factors that may influence people's response to treatment) to one of 2 intervention; Treatment as Usual (TAU) or TAU plus a therapist’s guide called the VIP (Victim Improvement Package). The VIP appears to reduce distress, but requires fuller evaluation. Proposed methods: (from HAVoC). Step 1: SNTs will identify older victims within a month of a crime and assess distress with 4 questions used by GPs. Distressed victims will be given written advice for their GP. Step 2: at 3 months, we will enquire whether they acted on the advice (some in detail) and reassess people to confirm depression and/or anxiety required and whether they would agree to step 3. Step 3: we will collect information on age, gender, ethnicity, marital status, previous occupation, level of education, and past illnesses (which may influence recovery), the crime, social support and what treatment they would like prior to randomising to: 1. TAU: usually GP support, voluntary sector help and (rarely) specialised psychological treatments or 2. TAU plus the VIP: up to 10 weekly sessions, over 3 months, given by a therapist from “Mind.” Outcomes: two scales of severity, the Beck Depression-II and Beck Anxiety Inventories, will be used together to compare changes in depression and/or anxiety. We will collect information on: quality of life; the use of health and social services. We will record who drops out and, if possible, why. Measures taken 3 months after the crime (just prior to the intervention) will be compared with the same measures collected at 6 months after the crime (after the intervention) and at 9 months after the crime (followup). Impact:The public health benefits are (i) to ensure successful identification of psychologically distressed older victims (ii) to improve psychological care for older people. (iii) if effective, to improve public health by rolling out the VIP nationally to reduce the continuation of symptoms.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH