Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Brain Activation and Connectivity in the Task-control Network (TCN)
研究概览
简要总结
This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to CBT.
The hypothesis of this trial is that CCT with CBT will further increase task control network (TCN) activation and connectivity.
Both groups will have one CBT therapy session each week for 12 weeks. However, for participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to complete during the two weeks prior to the first CBT session and during the two weeks after the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes just prior to CBT sessions 4-12.
Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment.
Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval.
Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
A clinician, blind to whether patients are completing CCT or not, will deliver CBT to the patients.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study
- •Must be actively enrolled and maintain eligibility in Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (HUM00118950; P.I. Fitzgerald) to participate in the study.
排除标准
- •Color blindness
结局指标
主要结局
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
时间窗: Baseline, 12 weeks (after therapy)
Pre- to post-CBT changes in brain activation and function connectivity in the task-control network including fronto-parietal and cingulo-opercular regions mediating cognitive control. Functional activation and connectivity of these brain regions are assessed using a conflict interference computer task performed during MRI scanning.
次要结局
- Change in Pediatric Anxiety Rating Score (PARS)(Baseline, 12 weeks (after therapy))
- Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox(Baseline, 12 weeks (after therapy))
- Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times(Baseline, 12 weeks (after therapy))
- Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy(Baseline, 12 weeks (after therapy))
研究者
Yanni Liu
Research Assistant Professor
University of Michigan