Patients with substance use disorders, psychotic disorders, affective disorders, anxiety disorders, acute anorexia nervosa, PTSD, ASPD, BPD, CD, ODD, ADHD, ASD with and without elevated aggressive behavior at study intake. F10-F19 F20-F29 F30-F39 F40-F48 F50-F59 F60-F69 F90-F98 F99
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: - psychiatric illness healthy controls: - no known psychiatric condition all: - age from 18 to 60 years old
Exclusion criteria
Exclusion criteria: Patients: - acute neurological or somatic condition Healthy controls: - acute psychiatric, neurological or somatic condition all: - acute suicidality - lack of ability to confirm their wish to participate in this study or inability to understand the project or give written confirmation to participate in this project MRI contraindications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypothesis H1: Group difference between active and yoked neurofeedback in the neural responses to high vs. low provocation during the Taylor-Aggression Paradigm (TAP). What is the Primary Endpoint? Confirmation of the group difference between active and yoked neurofeedback in the neural responses to high vs. low provocation during the Taylor-Aggression Paradigm (TAP) When is the primary endpoint measured, and how is it investigated? The fMRI data during the TAP are collected directly after the neurofeedback paradigm. The TAP is an established paradigm to investigate reactive aggression (Taylor, 1967 and e.g. Weidler et al., 2019) and can be implemented in an fMRI setting. The TAP entails different levels of provocation. Here, neural responses to high versus low provocation will be compared. After completion of data collection, the study will be unblinded and comparative statistics will be obtained. | — |
Secondary
| Measure | Time frame |
|---|---|
| H2a: We expect condition specific effects on neural networks during NF training and resting state measurements, i.e. higher responses in key nodes of the CCN and attenuated responses in Threat/ Frustrative Non –Reward network nodes?. What? We expect condition specific effects on neural networks during NF training and resting state measurements, i.e. higher responses in key nodes of the CCN and attenuated responses in Threat/ Frustrative Non –Reward network nodes?. When and how? During the NF-training and resting state measurements using fMRI network analysis. H2b: We expect an interaction between changes in reactive aggression measures (TAP) after CCN self-regulation and low versus high-GM density in the CCN? What? We expect an interaction between changes in reactive aggression measures (TAP) after CCN self-regulation and low versus high-GM density in the CCN?. When and how? The participants responses in the TAP will be investigated and a grey matter analysis will be conducted comparing low and high GM density in the CCN in participants. H3: Reduced state anger (STAXI-II) and less frequent aggressive events (EMA) in active NF compared to TaU?. What? We expect a reduced state anger (STAXI-II) and less frequent aggressive events (EMA) in active NF compared to TaU?. When and how? The STAXI-II will be conducted prior to and after the MRI measurement - including follow-up measurments. Additionally, the EMA sends notifications multiple times a week investigating aggressive events in the participants' day to day life. The indicated measures will be compared between the active NF and the TaU group. Exploration of neural correlates of group effects and intercepts and their association with psychometric measures, brain structure and demographic information. There is no explicit endpoint for the exploratory investigations. The aim is to explore the influence of multiple factors on the results of our experiment to better understand the data and inform future | — |
Countries
Germany
Contacts
Uniklinik RWTH Aachen