Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- University of Michigan
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in Brain Activation and Connectivity in the Task-control Network (TCN)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Yanni Liu
Research Assistant Professor
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Color blindness
Outcomes
Primary Outcomes
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
Time Frame: 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.
Secondary Outcomes
- 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))