Blame Rebalance fMRI Feedback Proof-of-concept (GUIMRINFB1)

D'Or Institute for Research and Education

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: GUILT-STABILIZE-CORRELATION; Device: GUILT-INCREASE-CORRELATION

Study type: Interventional

Funder types: Other

Identifiers

NCT01920490

IDOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

GUILT-INCREASE-CORRELATION

Experimental group

Description:

Patients in this group will receive visual feedback that reinforces increasing the correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will reinforce stabilization of the preceding degree of correlation.

Treatment:

Device: GUILT-INCREASE-CORRELATION

GUILT-STABILIZE-CORRELATION

Active Comparator group

Description:

Patients in this group will receive visual feedback that reinforces stabilization of the preceding degree of correlation in fMRI signal between the right superior anterior temporal and septal-subgenual regions during the retrieval of predefined guilt-related autobiographical episodes. During the indignation condition, visual feedback will also reinforce stabilization of the preceding degree of correlation.

Treatment:

Device: GUILT-STABILIZE-CORRELATION