Rebalancing Blame Using fMRI Neurofeedback: a Double-blind Controlled Clinical Proof-of-concept Trial in Remitted Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Increase in correlation between anterior temporal and subgenual frontal fMRI signal for guilt relative to indignation
时间窗: 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.
次要结局
- Beck Depression Inventory(Change from baseline after one session of fMRI neurofeedback training)
- Interpersonal Guilt Questionnaire - Self-hate subscale(Change from baseline after one session of fMRI neurofeedback training)
- Rosenberg Self-Esteem Scale(Change from baseline after one session of fMRI neurofeedback)