Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1
研究概览
简要总结
A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.
详细描述
This phased innovation application in response garnered support for an initial (R61) 2-year phase for milestone-driven testing of neural targets of intervention by a novel neurofeedback treatment. Using neurofeedback (NF) we targeted the neurocircuitry of affect regulation and self-processing in adolescents and young adults (ages 11-18) with current significant suicide ideation and a history of a recent suicide attempt. Attaining our the milestones would trigger support for three additional years (R33 phase) to confirm target engagement in a larger sample with random assignment to active NF intervention vs. Placebo NF, to assess the relationships between target engagement and changes in functional outcomes. Affect dysregulation and abnormal self-processing are known to contribute to poor long-term outcomes and predict repeated suicide attempts in at risk populations. They are insufficiently addressed by medications or most existing behavioral treatments. NF training has resulted in enduring improvements in those dimensions in prior Placebo controlled NF trials. To further develop this intervention, we first identified the neural target best engaged by NF during a critical developmental period for affect regulation and self-processing. Our pilot data and theoretical considerations supported the overarching hypothesis that increased amygdala or dACC activity and their functional connectivity (FC) with the middle prefrontal cortex (mPFC) represented treatable targets via NF training. Accordingly, in the initial R61 phase measured intervention-related increases in dACC and right amygdala activity and their FC with mPFC during self-processing and affect regulation tasks with high-quality imaging and clinical data obtained during, before and after NF training. The goal of the R61 phase was to determine which loci is best up-regulated by the targeted population and was best associated with amelioration in the target functional outcomes. If we were to meet our proposed milestones that the increase in dACC or right amygdala and their FC with the mPFC exceeded a specific effect size and account for an appreciable proportion of the variance in behavioral measures of affect regulation and self-processing, we would proceed to the R33 phase. In the R33 phase, we would expand the study to test adolescents randomized to the active NF intervention (dACC or Amygdala) or to a placebo NF who would provide complete high quality pre- and post-intervention and clinical data. We obtained state-of-the-art magnetic resonance imaging (MRI) data with a primary focus on functional MRI. Our specific aims in the R33 phase would be to confirm target engagement in the groups randomized to active vs. the Placebo NF group; to examine the relationship between changes in the neural target and clinical improvements in affect regulation, self-processing and suicide ideation; and to identify mediators of improved functional outcomes. Evidence supporting the validity of dACC or amygdala circuits as a modifiable neural target would then support future studies to further enhance the effectiveness of neurofeedback in adolescents. Importantly, even negative results would be informative regarding the location and direction of neurofeedback (top=dACC vs. down=amygdala) that best attains substantial effects. Inconclusive results from brain imaging would still inform Bayesian priors for future studies of the neural substrates of affect regulation and self-processing impairments and their amelioration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents with a history of suicide attempts
排除标准
- •Psychotic disorders.
- •Primary substance use disorder.
- •Primary anorexic disorder.
- •Autism Spectrum Disorder.
研究组 & 干预措施
dACC Arm
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
干预措施: neurofeedback training involving dACC (Other)
rAMY Arm
Participants assigned to the Neurofeedback from the amygdala
干预措施: neurofeedback training involving amygdala (Other)
结局指标
主要结局
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1
时间窗: Day 0
The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 4
时间窗: Week 11
The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 5
时间窗: Week 16
The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Suicide Ideation Questionnaire (SIQ) - Visit 1
时间窗: Day 0
Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Suicide Ideation Questionnaire (SIQ) - Visit 4
时间窗: Week 11
Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Suicide Ideation Questionnaire (SIQ) - Visit 5
时间窗: Week 16
Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Neural Target Engagement - Visit 2
时间窗: Week 5
Activity for the Neural Target indicates level of blood oxigen level dependent activity as obtained via functional magnetic resonance imaging. Higher levels indicate more activity in the area of interest compared to baseline states of the brain.
Neural Target Engagement - Visit 3
时间窗: Week 8
Activity for the Neural Target indicates level of blood oxigen level dependent activity as obtained via functional magnetic resonance imaging. Higher levels indicate more activity in the area of interest compared to baseline states of the brain.
次要结局
- Difficulties in Emotion Regulation (DERS) - Visit 1(Day 0)
- Difficulties in Emotion Regulation (DERS) - Visit 2(Week 5)
- Difficulties in Emotion Regulation (DERS) - Visit 3(Week 8)
- Difficulties in Emotion Regulation (DERS) - Visit 4(Week 11)
- Difficulties in Emotion Regulation (DERS) - Visit 5(Week 16)
- Responses to Depression (RD) - Visit 1(Day 0)
- Responses to Depression (RD) - Visit 2(Week 5)
- Responses to Depression (RD) - Visit 3(Week 8)
- Responses to Depression (RD) - Visit 4(Week 11)
- Responses to Depression (RD) - Visit 5(Week 16)
- Children's Depression Rating Scale - Visit 1(Day 0)
- Children's Depression Rating Scale - Visit 4(Week 11)
- Children's Depression Rating Scale - Visit 5(Week 16)