Skip to main content
OpenTrials
Completed

NCT Number: NCT01920490

Blame Rebalance fMRI Feedback Proof-of-concept

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, 22290-140, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • past major depressive episode according to Diagnostic Statistical Manual (DSMIV) for at least 2 months, currently not fulfilling criteria for depression and remitted from symptoms for at least 2 months

Exclusion criteria

  • suicidal thoughts
  • other current DSM-IV axis-I disorders
  • a history of atypical major depressive episodes (DSM-IV)
  • Global Assessment of Functioning scores below 80 as a sign of incomplete remission or co-morbidity
  • >2 points on the suicidality item of the Hamilton Depression Scale
  • prior criminal convictions
  • history of violent behavior towards persons as determined by clinical interview
  • positive past or current screening question for irritability on the mood disorders module
  • antisocial personality as determined on personality interview using DSM-IV criteria
  • borderline personality disorder as determined on personality interview using DSM-IV criteria according to the personality interview
  • current self-harming behaviors

Treatment and study plan

GUILT-INCREASE-CORRELATION

Device

This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner

GUILT-STABILIZE-CORRELATION

Device

This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner

Primary outcomes

  1. Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation

    Time frame: change from baseline after one session of fMRI neurofeedback training

    Correlations are computed by using average signal in the most highly activated voxels within a priori regions of interest in the right superior anterior temporal and septal/subgenual cingulate region. The same a priori regions are also used to provide neurofeedback.

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: Change from baseline after one session of fMRI neurofeedback training

    This is an outcome measure to ensure the safety of our intervention, we expect that one session of fMRI neurofeedback will not lead to a significant increase in Beck Depression Inventory scores when comparing scores after and before the training session.

  2. Interpersonal Guilt Questionnaire - Self-hate subscale

    Time frame: Change from baseline after one session of fMRI neurofeedback training

    This is an exploratory outcome measure to determine whether there is a detectable effect on self-blaming emotions after one session of fMRI neurofeedback. This is not our primary aim in that this study is primarily designed to determine feasibility and safety rather than efficacy.

  3. Rosenberg Self-Esteem Scale

    Time frame: Change from baseline after one session of fMRI neurofeedback

    This is an exploratory outcome measure to determine whether there is a detectable effect on global self-esteem after one session of fMRI neurofeedback. This is not our primary aim in that this study is primarily designed to determine feasibility and safety rather than efficacy.

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Registry information

Official study title

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

Acronym: GUIMRINFB1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 12, 2013
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.