Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents
Condition: Aggression; Conduct Disorder
MeSH terms: Aggression; Conduct Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. Can participants gain increasing control over the activation of defined brain regions
           through real-time fMRI training?

        2. 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.

      After completion of this pretest, subjects meeting the inclusion criteria for the rt-fMRI
      treatment study will be randomly assigned to two different treatment arms, either to the
      experimental fMRI real-time feedback condition or to the comparator condition with treatment
      as usual (TAU) lasting 10 weeks. Subjects assigned to the experimental condition will receive
      10 sessions (1/week) of real-time fMRI feedback of amygdala and/or insula activation (based
      on activation patterns during pre-training assessment). Each training will last about 1 1/2
      hours and consist of 3 experimental blocks, including feedback- and transfer trials. Video
      clips of emotional and aggressive interpersonal interactions will partly be used to enrich
      feedback conditions with naturalistic, virtual reality type displays. Heart rate and
      electrodermal activity will be recorded simultaneously during the sessions. Subjects in the
      comparator TAU arm will receive several sessions of psychoeducation and counseling with their
      parents/caregivers or group training over the 10 weeks.

      After completion of either the training or the TAU, subjects will undergo post-treatment
      assessment, repeating the teachers and parents reports on behavioral measures, as well as the
      neuropsychological testing, fMRI and MRS. A follow-up assessment will take place 6 months
      after the end of the treatment phase and will comprise only parents and teachers reports on
      behavioral measures.
    

Intervention name(s): Real-time fMRI feedback; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): feedback about activation patterns in brain regions related with instrumental aggression; Psychoeducation, general counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Real-time fMRI feedback