Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents (Part of EU-MATRICS: Multidisciplinary Approaches to Translational Research)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes in aggressive behavior from baseline at 10 weeks and 6 months as assessed by the Modified Overt Aggression Scale (MOAS)
研究概览
简要总结
The purpose of this study is to determine whether real-time fMRI feedback is effective in the treatment of aggressive behavior problems in adolescents with high callous unemotional traits when compared to treatment as usual.
详细描述
In this study, which is part of the European research project MATRICS (Multidisciplinary Approaches to Translational Research), the investigators focus on testing an innovative, non-pharmacological therapeutic approach for adolescents with a specific, difficult to treat subtype of aggressive behavior problems. Participants will be trained to acquire control over their own physiological parameters, in case of this study the activation of certain brain areas. While trying to control these parameters, participants get direct continuous feedback about their physiological state and its changes, and are rewarded for successful manipulation. Biofeedback methods are currently used to treat patients with a variety of psychiatric disorders such as attention-deficit/hyperactivity disorder (ADHD).
Here, real-time functional magnetic resonance imaging (rt-fMRI) feedback will be used, where participants will get feedback about activation levels and patterns from brain regions associated with emotion processing (amygdala/insula) in almost real time while lying in a magnetic resonance tomograph scanner.
Investigators will focus on the following questions concerning the effectiveness of this treatment approach:
- Can participants gain increasing control over the activation of defined brain regions through real-time fMRI training?
- Which short- and longer term consequences can be expected from improved self control over brain activation upon aggressive and antisocial behavior problems?
Before the training, all participants will undergo an extensive pre-treatment assessment as part of the characterization and subtyping of aggression within the large multicenter subtyping studies (EU-Aggressotype and EU-MATRICS). The assessment includes clinical and psychometric measures, neuropsychological testing, fMRI (3 active tasks + resting state), MRS (anterior cingulate cortex (ACC) and insula) and diffusion tensor imaging (DTI) as well as biosampling (blood/saliva for genetics/epigenetics/hormones). Comparison with a typically developing (TD) control group receiving no intervention will allow to interpret changes in terms of normalization or compensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(interventional group):
- •ODD/CD diagnosis based on the DSM-5 criteria
- •aggression in the clinical range, T > 70 on the aggression or delinquency subscale of the Teacher Report Form (TRF), Youth Self Report (YSR) or Child Behaviour Checklist (CBCL)
- •preferably medication-naive, otherwise medication should be stable for at least 2 months
- •Inclusion Criteria (typically developing (TD) group):
- •no diagnosis based on the DSM-5 criteria
- •aggression below the clinical range, T < 70 on the aggression or delinquency subscale of the Teacher Report Form (TRF), Youth Self Report (YSR) or Child Behaviour Checklist (CBCL)
排除标准
- •(both groups):
- •a primary DSM-5 diagnosis of psychosis, bipolar disorder, depression or anxiety
- •contra-indications for MRI scanning, e.g. presence of metal parts in the body
结局指标
主要结局
Changes in aggressive behavior from baseline at 10 weeks and 6 months as assessed by the Modified Overt Aggression Scale (MOAS)
时间窗: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)
Parents or caregivers report on type and intensity of aggressive behavior over the last weeks (questionnaire)
次要结局
- Changes in composition of neurotransmitter systems from baseline at 10 weeks after the beginning of the treatment phase as assessed by MRS(Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase))
- Changes in brain activation from baseline at 10 weeks after the beginning of the treatment phase as assessed by fMRI(Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase))
- Changes in aggressive behavior from baseline at 10 weeks and at 6 months as reported by teachers through the aggressive behavior subscale of the TRF (Teachers Report Form)(Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment))