Background
Objectives
Methods/design
Study design
Ethical approval
Population
Location
Recruitment methods and procedures
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Step 1
Summary of main measures (all with reference to post crime) | Post-crime eligibility check | Enrolment | Post allocation | Closeout | ||
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0 (post crime) | 3 months | Baseline 3 months | Post intervention 6 months | Follow-up 9 months | ||
Enrolment: | ||||||
Post-crime eligibility screen | X | |||||
Baseline eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Interventions: | ||||||
Victim Improvement Package | X | |||||
Treatment as usual | X | |||||
Assessments: | ||||||
BDI-II | X | X | X | |||
BAI | X | X | X | |||
MINI (caseness)/specific anxiety disorder | X | X | ||||
EQ5-D | X | X | X | |||
CSRI | X | X | X | |||
Childhood Trauma Questionnaire | X | |||||
Safety Behaviour Questionnaire | X | X | X | |||
Satisfaction with VIP | X | |||||
Expectation of therapy | X | |||||
Blindness assessment by research assistant | X | X | ||||
Attrition and reason | X | X | ||||
Fidelity: adherence and CTS-R | X |
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Step 2
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Step 3
Eligibility criteria
Risk management
Randomisation
Descriptions of the interventions
The Victim Improvement Package (VIP)
Treatment as usual (TAU)
Outcomes
Primary outcomes
Secondary outcomes
Other measures
Childhood Trauma Questionnaire
A measure of safety behaviours
Measures of sources of bias during the course of the trial
Timing of enrolment, interventions and measures
Assessment of therapists’ competence and adherence to VIP manual
Data entry and storage
Trial monitoring
Statistics
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BDI-II scores will be standardised by the mean and standard deviation of BDI- II score at baseline of all participants in the depression stratum irrespective of allocation
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BAI scores will be standardised by the mean and standard deviation of BAI score at baseline of all participants in the anxiety-only stratum irrespective of allocation
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The standardised versions of BDI-II scores from the depression stratum and BAI scores from the anxiety-only stratum will then be combined into a single variable to form the primary outcome measure, used in the linear mixed-effects regression model