AggressionNCT02563145
Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents
A study testing Real-time fMRI feedback and Treatment as usual in people with Aggression and Conduct Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression, Conduct Disorder
- What is being tested?
- Real-time fMRI feedback and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- 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)
Who cannot join
- IQ<80
- 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
- epilepsy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany
Mannheim, 68159
About this study
Official title: Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents (Part of EU-MATRICS: Multidisciplinary Approaches to Translational Research)
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.
Read the 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:
- 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.
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.
- Conditions
- Aggression, Conduct Disorder
- Being tested
- Real-time fMRI feedback, Treatment as usual
- Keywords
- Real-time fMRI feedback
- Medical subject headings
- Aggression, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI feedbackBehavioural
feedback about activation patterns in brain regions related with instrumental aggression
Treatment as usualBehavioural
Psychoeducation, general counselling
| Study group | Role | What they receive |
|---|---|---|
| Real-time fMRI feedback | Experimental | After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the experimental condition will receive 10 sessions of real-time fMRI feedback of insula- or amygdala activation (dependent on activation patterns during pre-testing), 1 session/week. Each session will last about 1 1/2 hours.
After training completion (10 weeks after the beginning of the treatment phase), subjects will undergo post-treatment assessment and follow up (6 months after the end of the training phase). Receives: Behavioral: Real-time fMRI feedback |
| Treatment as usual | Active comparator | After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the comparator TAU arm will receive several sessions of psychoeducation and counseling with their parents/caregivers or group training over 10 weeks.
Within the sessions, investigators will focus on psychoeducational issues and provide general counseling for the families. After 10 weeks, subjects will undergo post-treatment assessment and follow up (6 months after the end of the treatment phase). Receives: Behavioral: Treatment as usual |
| Typically developing (TD) control group | No intervention | Healthy typically developing subjects will only participate in pre-training assessment to allow for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in aggressive behavior from baseline at 10 weeks and 6 months as assessed by the Modified Overt Aggression Scale (MOAS)
Parents or caregivers report on type and intensity of aggressive behavior over the last weeks (questionnaire)
Measured: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)
Secondary outcomes (3)
Changes in brain activation from baseline at 10 weeks after the beginning of the treatment phase as assessed by fMRI
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.
Measured: Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase)
Changes in composition of neurotransmitter systems from baseline at 10 weeks after the beginning of the treatment phase as assessed by MRS
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)
Measured: 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)
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)
Measured: Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Brandeis, PhD, Principal investigator, Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, GermanyTobias Banaschewski, MD, PhD, Principal investigator, Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563145
- Sponsor's protocol ID
- EU Health-F2-2013-603016
- Status last verified
- Feb 2023
- First submitted
- 28 Sep 2015
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents (Part of EU-MATRICS: Multidisciplinary Approaches to Translational Research)
- ClinicalTrials.gov ID
- NCT02563145
- Acronym / sponsor ID
- EU Health-F2-2013-603016
- Conditions
- Aggression, Conduct Disorder
- Keywords
- Real-time fMRI feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real-time fMRI feedback | Experimental | Behavioral: Real-time fMRI feedbackAfter a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the experimental condition will receive 10 sessions of real-time fMRI feedback of insula- or amygdala activation (dependent on activation patterns during pre-testing), 1 session/week. Each session will last about 1 1/2 hours. After training completion (10 weeks after the beginning of the treatment phase), subjects will undergo post-treatment assessment and follow up (6 months after the end of the training phase). |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualAfter a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the comparator TAU arm will receive several sessions of psychoeducation and counseling with their parents/caregivers or group training over 10 weeks. Within the sessions, investigators will focus on psychoeducational issues and provide general counseling for the families. After 10 weeks, subjects will undergo post-treatment assessment and follow up (6 months after the end of the treatment phase). |
| Typically developing (TD) control group | No intervention | –Healthy typically developing subjects will only participate in pre-training assessment to allow for comparison. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- 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)
Key exclusion criteria (4 listed)
- IQ<80
- 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
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time fMRI feedbackfeedback about activation patterns in brain regions related with instrumental aggression | Behavioural | Real-time fMRI feedback |
| Treatment as usualPsychoeducation, general counselling | Behavioural | Treatment as usual |
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)
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Brandeis, PhD principal investigator
Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany
Tobias Banaschewski, MD, PhD principal investigator
Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time fMRI feedback and Treatment as usual in people with Aggression and Conduct Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.