Clinical trial NCT01920490: Blame Rebalance fMRI Feedback Proof-of-concept
Official title: Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation
timeFrame: change from baseline after one session of fMRI neurofeedback training
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Change from baseline after one session of fMRI neurofeedback training
measure: Interpersonal Guilt Questionnaire - Self-hate subscale
timeFrame: Change from baseline after one session of fMRI neurofeedback training
measure: Rosenberg Self-Esteem Scale
timeFrame: Change from baseline after one session of fMRI neurofeedback
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Study officials:
affiliation: D'Or Institute for Research and Education
name: Jorge Moll, MD PhD
role: STUDY_DIRECTOR
affiliation: D'Or Institute for Research and Education
name: Roland Zahn, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: D'Or Institute for Research and Education
name: Paulo Mattos, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: D'Or Institute for Research and Education
name: Ricardo de Oliveira-Souza, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
name: Leonardo F Fontenelle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green S, Lambon Ralph MA, Moll J, Deakin JF, Zahn R. Guilt-selective functional disconnection of anterior temporal and subgenual cortices in major depressive disorder. Arch Gen Psychiatry. 2012 Oct;69(10):1014-21. doi: 10.1001/archgenpsychiatry.2012.135.
citation: Zahn R, Weingartner JH, Basilio R, Bado P, Mattos P, Sato JR, de Oliveira-Souza R, Fontenelle LF, Young AH, Moll J. Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial. Neuroimage Clin. 2019;24:101992. doi: 10.1016/j.nicl.2019.101992. Epub 2019 Aug 25.