Blame Rebalance fMRI Feedback Proof-of-concept — GUIMRINFB1  

Major Depressive Disorder Clinical Trial

Official title: Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder

Status Completed

Clinical Trial Summary

The investigators have shown that decoupling of brain networks when feeling guilty is the first potential functional neuroimaging biomarker of risk of major depression. It remains detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was found while people felt guilty during functional magnetic resonance imaging (fMRI) relative to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for interventions to reduce the largely increased risk of recurrent episodes in people who have had one episode but are currently remitted. To our knowledge, however, there is no proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected and fed back to the participants after a short temporal delay in a real-time fMRI setting and whether coupling can be increased through neurofeedback training. This project aims at developing the first fMRI neurofeedback system to treat self-blame-selective neural decoupling and to test its feasibility in people with major depressive disorder currently remitted from symptoms.

Clinical Trial Description

Specific aim 1: Demonstrate that anterior temporal lobe (ATL)-septal/subgenual cingulate (SCSR) coupling for guilt can be increased through one session of neurofeedback in the group seeing visual feedback based on increasing correlations during the guilt condition compared with the group seeing visual feedback based on keeping correlations at the same level during the guilt condition.

Specific aim 2: Demonstrate that this increase in coupling is selective for guilt relative to indignation.

Specific aim 3: Demonstrate that mood is not negatively affected by neurofeedback.

Specific aim 4: Explore whether this short intervention decreases self-hate on the Interpersonal Guilt Questionnaire (Portuguese translation) and increases self-esteem on the Rosenberg scale (both show significant correlations with SCSR-ATL coupling across major depressive disorder and control groups in our Manchester study), or if these measures are not available, decreases negative affect on the Positive and Negative Affect Scale. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT01920490
• Study type: Interventional
• Source: D'Or Institute for Research and Education
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Completion date: October 2014