Study of Neurofeedback Training as an Adjunctive Transdiagnostic Treatment among Adolescents with Internalizing Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary clinical outcome will be the change in transdiagnostic internalizing symptom severity, assessed from baseline to post-intervention, using a composite score derived from the Child Behavior Checklist (CBCL), Screen for Child Anxiety Related Disorders (SCARED), and Childhood Depression Inventory-II (CDI-II). These tools will capture a broad spectrum of internalizing symptoms including anxiety, depression, and related behavioral/emotional difficulties, allowing for a robust measure of clinical change across diagnostic boundaries. The primary neural outcome will be the change in the specific neurophysiological marker targeted by neurofeedback ( EEG-derived PCC/dACC activity), measured pre- and post-intervention using standardized acquisition and preprocessing protocols. This will provide a mechanistic indicator of neurofeedback efficacy in modulating relevant brain networks associated with internalizing disorders.
研究概览
简要总结
This study investigates the efficacy of infra-slow EEG neurofeedback training as an adjunctive transdiagnostic intervention for adolescents diagnosed with internalizing disorders, including anxiety and depression. Utilizing a quasi-experimental pre-test, post-test, and follow-up design, the study aims to evaluate changes in symptom severity and transdiagnostic factors such as emotional regulation, attentional control, and rumination. Participants will be assigned to either an intervention group receiving infra-slow closed-loop neurofeedback targeting the dorsal anterior cingulate cortex (dACC) and posterior cingulate cortex (PCC), or a waitlist control group receiving treatment-as-usual. Neurofeedback sessions will be conducted twice weekly over a defined period, using a 128-channel Geodesic Sensor Net and real-time feedback mechanisms. Outcomes will be assessed using standardized psychometric instruments including the Screen for Child Anxiety Related Emotional Disorders (SCARED), Beck Depression Inventory-II (BDI-II), Difficulties in Emotion Regulation Scale (DERS), and Ruminative Response Scale (RRS), alongside neurophysiological measures derived from EEG source localization. The study seeks to establish neurofeedback as a viable, non-pharmacological adjunct for improving clinical and functional outcomes in adolescents with internalizing disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 11.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 11 to 17 years Both male and female Adolescents with IQ above 85 (on WISC -IV) Diagnosis of internalizing disorder (CBCL score above 65 in internalizing disorders)in one or more including anxiety disorders (generalised anxiety, social anxiety, separation anxiety and depressive disorders (Major depressive disorders, dysthymia)diagnosed according to ICD -10, and DSM (Additional use of ICD-11) Internalizing disorders comorbid with academic problems and dissociative disorders (T-score above 65 in internalizing disorder measured by CBCL) Participants giving informed assent and consent.
排除标准
- •History of Organic Psychiatric Diagnosis History of substance use measured by WHO-ASSIST-Y Co-morbid psychiatric diagnosis (except academic problems and dissociative disorders) Secondary diagnosis of depression due to other medical or psychiatric concerns Has current suicidal ideation measured by SIQ History of chronic or other significant general medical or neurological conditions Having physical/sensory disability.
结局指标
主要结局
The primary clinical outcome will be the change in transdiagnostic internalizing symptom severity, assessed from baseline to post-intervention, using a composite score derived from the Child Behavior Checklist (CBCL), Screen for Child Anxiety Related Disorders (SCARED), and Childhood Depression Inventory-II (CDI-II). These tools will capture a broad spectrum of internalizing symptoms including anxiety, depression, and related behavioral/emotional difficulties, allowing for a robust measure of clinical change across diagnostic boundaries. The primary neural outcome will be the change in the specific neurophysiological marker targeted by neurofeedback ( EEG-derived PCC/dACC activity), measured pre- and post-intervention using standardized acquisition and preprocessing protocols. This will provide a mechanistic indicator of neurofeedback efficacy in modulating relevant brain networks associated with internalizing disorders.
时间窗: mid-intervention, 1 week post-intervention and 3-month follow-up
次要结局
- Secondary clinical outcomes will include changes in transdiagnostic process variables such as emotion regulation, rumination, and attentional control, measured using the Difficulties in Emotion Regulation Scale (DERS), Ruminative Response Scale (RRS), and Attentional Control Scale for Children (ACS-C). These measures will allow investigation of potential mediators of clinical change and clarify the pathways through which neurofeedback exerts its effects. Feasibility and acceptability will be assessed through retention, adherence, and participant feedback, while socio-demographic and baseline cognitive functioning (via WISC-IV) will be used to examine potential moderators of treatment response.(mid-intervention, 1 week post-intervention and 3-month follow-up)
研究者
Snehaa
AIl India Institute of Medical Sciences , New Delhi