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一项基于互联网的干预措施对法医精神病门诊患者攻击行为治疗的附加价值——一项多中心、混合方法随机对照试验的研究方案

The added value of an internet-based intervention for treatment of aggression in forensic psychiatric outpatients-study protocol for a multicentre, mixed-methods randomized controlled trial.

作者信息

Kip Hanneke, Haneveld Lisa Klein, Kelders Saskia M

机构信息

Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Enschede, The Netherlands.

Department of Research, Stichting Transfore, Deventer, The Netherlands.

出版信息

Digit Health. 2024 Dec 12;10:20552076241303835. doi: 10.1177/20552076241303835. eCollection 2024 Jan-Dec.

Abstract

BACKGROUND

Even though internet-based interventions have been used in treatment of forensic psychiatric outpatients for over 10 years, no robust effectiveness studies have been conducted in this complex branch of mental healthcare.

OBJECTIVES

To present the protocol of a study that investigates whether the addition of the internet-based intervention "Dealing with Aggression" to treatment as usual (TAU) leads to better treatment outcomes than TAU that is delivered solely in-person.

METHODS

This study uses a multicentre mixed-methods randomized controlled trial (RCT) design, with four Dutch forensic outpatient organizations. Patients are included if they receive outpatient treatment for aggression. They will be randomized into an experimental condition, in which the intervention is added to TAU (n = 64), or a control condition, with only TAU (n = 64). Participants are assessed four times: at baseline (T0), halfway during the 10-week intervention (T1), after completing the intervention (T2), and after 3 months (T3). Primary outcome measure is self-reported aggression, other outcome measures are regulatory emotional self-efficacy and treatment readiness, the number of treatment sessions, and dynamic risk factors. Adherence to and engagement with the internet-based intervention will be investigated as predictors for effectiveness. Perceived effect and points of improvement are identified via semistructured interviews with patients and therapists.

DISCUSSION

This will be the first study to investigate the effectiveness of an internet-based intervention in a forensic psychiatric outpatient sample. By means of the mixed-methods design and use of adherence and engagement as predictors, this study will answers questions about if, but also why and for whom this intervention works.

摘要

背景

尽管基于互联网的干预措施已用于法医精神病门诊患者的治疗超过10年,但在这一复杂的精神卫生保健分支领域尚未进行有力的有效性研究。

目的

介绍一项研究方案,该研究旨在调查在常规治疗(TAU)基础上增加基于互联网的“应对攻击行为”干预措施是否比单纯面对面的TAU能带来更好的治疗效果。

方法

本研究采用多中心混合方法随机对照试验(RCT)设计,涉及四个荷兰法医门诊机构。如果患者因攻击行为接受门诊治疗,则纳入研究。他们将被随机分为实验组(在TAU基础上增加干预措施,n = 64)或对照组(仅接受TAU,n = 64)。对参与者进行四次评估:基线时(T0)、10周干预期中间(T1)、干预结束后(T2)和3个月后(T3)。主要结局指标是自我报告的攻击行为,其他结局指标包括调节情绪自我效能感和治疗准备情况、治疗疗程数以及动态风险因素。将对基于互联网干预措施的依从性和参与度进行调查,作为有效性的预测指标。通过对患者和治疗师的半结构化访谈确定感知到的效果和改进点。

讨论

这将是第一项调查基于互联网的干预措施在法医精神病门诊样本中的有效性的研究。通过混合方法设计以及将依从性和参与度用作预测指标,本研究将回答关于该干预措施是否有效、为何有效以及对谁有效的问题。

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