Clinical Trial: Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents (Part of EU-MATRICS: Multidisciplinary Approaches to Translational Research)

Brief 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 Summary:

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 st
Sponsor: Central Institute of Mental Health, Mannheim

Current Primary Outcome: Changes in aggressive behavior from baseline at 10 weeks and 6 months as assessed by the Modified Overt Aggression Scale (MOAS) [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in brain activation from baseline at 10 weeks after the beginning of the treatment phase as assessed by fMRI [ Time Frame: Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase) ]
    At baseline and at the end of the treatment phase, patients will perform 3 functional tasks in the fMRI. The tasks used are: Stop-Signal Task, Emotional Faces task, Passive Avoidance task.
  • Changes in composition of neurotransmitter systems from baseline at 10 weeks after the beginning of the treatment phase as assessed by MRS [ Time Frame: Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase) ]
    At baseline and at the end of the treatment phase, patients will undergo magnetic resonance spectroscopy (MRS) of two brain areas implicated in inhibitory control (ACC and insula)
  • 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) [ Time Frame: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment) ]
    At baseline, after the end of the treatment phase (10 weeks) and at follow up (6 months), teachers will be asked to complete the TRF, which is a questionnaire focusing on general psychopathology ( and allows to differentiate between several subsets of symptoms, amongst others those indicating externalizing and aggressive behavior)


Original Secondary Outcome: Same as current

Information By: Central Institute of Mental Health, Mannheim

Dates:
Date Received: September 28, 2015
Date Started: October 2015
Date Completion: April 2019
Last Updated: September 28, 2015
Last Verified: June 2015