Reporting outcomes of back pain trials: a modified Delphi study.

Many patients residing in forensic psychiatric centers have difficulties regulating their aggression in an adequate manner. Therefore, they are frequently involved in conflicts. Evidenced-based aggression therapies in forensic psychiatry are scarce, and due to the highly secured environment, it is hard to practice real-life provocations. We have developed a Virtual Reality aggression prevention training (VRAPT), providing safe virtual environments, in which patients can practice controlling their aggressive behaviors in an adequate way. The main objective of this study is to examine whether VRAPT is effective in reducing aggression among forensic psychiatric inpatients. Four forensic psychiatric centers in the Netherlands are participating in this study. Participants will be randomly assigned to either VRAPT or a waiting list. The two groups will be compared at several different time points: baseline (12 weeks before intervention), pre-intervention, post-intervention and at 12 weeks follow-up. After follow-up measurements are completed, participants from the waiting list will also receive VRAPT. The primary outcome is level of aggressive behavior, consisting of staff-reported and self-reported measures. Secondary outcomes are self-report questionnaires on e.g., anger, impulsivity and aggression. To the best of our knowledge this is the first study to examine the effectiveness of a VR aggression prevention training in forensic psychiatric centers. Further details on the methodological issues are discussed in this paper. Dutch Trial Register (
 NTR, TC = 6340
 ). Retrospectively registered 14–04-2017.

/pdf/effect-of-virtual-reality-aggression-prevention-training-for-39gt92m2oc.pdf

Effect of virtual reality aggression prevention training for forensic psychiatric patients (VRAPT): study protocol of a multi-center RCT

The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (2001) (Part II).

/pdf/the-revised-consort-statement-for-reporting-randomized-49kv459tjg.pdf

N. Chipigina

Papers

The revised consort statement for reporting randomized trials: explanation and elaboration (2001) (part ii)