Serfaty Marc, Aspden Trefor, Satchell Jessica, Kessel Anthony, Laycock Gloria, Brewin Chris R, Buszewicz Marta, O'Keeffe Aidan, Hunter Rachael, Leavey Gerard, Cuming-Higgs Jon, Drennan Vari, Riveros Monica, Andrew David, Blanchard Martin
Division of Psychiatry, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.
Priory Hospital North London, London, N14 6RA, UK.
Trials. 2020 Apr 16;21(1):333. doi: 10.1186/s13063-020-4211-9.
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.
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.
International Standard Randomised Controlled Trials Number, ID: ISRCTN16929670. Registered on 3 August 2016.
老年人在遭受犯罪后容易长期处于高水平的心理社会困扰之中。一种基于认知行为疗法（CBT）的心理治疗方法，即受害者改善套餐（VIP），可能有助于康复。VIP试验旨在测试VIP在减轻老年犯罪受害者抑郁和焦虑症状方面的临床效果和成本效益。
方法/设计：年龄在65岁及以上且报告曾是犯罪受害者的人，将在犯罪发生后一个月内由伦敦警察厅邻里安全小组使用患者健康问卷-2和广泛性焦虑症问卷-2对其困扰程度进行筛查。筛查呈阳性的人将被指引至其家庭医生处寻求帮助，并在3个月后再次进行筛查。在再次筛查中抑郁和/或焦虑呈阳性的参与者将被随机分为两组，一组接受在常规治疗（TAU）基础上增加的基于CBT的VIP治疗，另一组仅接受TAU治疗。干预措施包括10次每次1小时的个体治疗，由心理健康慈善机构“心灵”的治疗师每周进行一次。主要结局指标是贝克抑郁量表第二版（BDI-II）和贝克焦虑量表（BAI），将其作为综合指标，在犯罪发生6个月后（治疗后）进行评估，并在犯罪发生9个月后进行随访。次要结局指标包括EQ-5D和改良的客户服务收据清单。总共226名参与者将以1:1的比例随机分为VIP组和TAU组，以便使用具有90%检验效能和5%显著性水平的混合效应线性回归模型（对治疗师聚类和潜在脱落情况进行调整）检测两组之间至少0.5的标准化差异。成本效益分析将纳入干预成本，以比较各治疗组之间的总体医疗保健成本和生活质量年数。一项嵌入式研究将考察既往创伤、安全行为参与情况和困扰对主要结局的影响。
这项试验应能提供有关针对有焦虑和/或抑郁症状的老年犯罪受害者的基于CBT的心理治疗的临床效果和成本效益的数据，并应展示一种跨机构综合协作的模式。我们的研究结果应为政策制定者、委托方和临床医生应对老年犯罪受害者的需求提供证据。
国际标准随机对照试验编号，ID：ISRCTN16929670。于2016年8月3日注册。
