Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety
Study Details
Study Description
Brief Summary
This study will assign eighteen participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll thirty-six 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBT and computerized cognitive training (CCT) Participants will play CCT games at home 5 times per week for two weeks before beginning CBT and for two weeks after the first CBT session. Then participants will have CCT games immediately prior to CBT for nine more weeks (one time a week). |
Behavioral: Cognitive behavioral therapy (CBT)
The CBT intervention will consist of 12 weekly 60 minute sessions of the manualized therapy, adapted from the Coping Cat program, for the treatment of pediatric anxiety disorders.
Behavioral: computerized cognitive training (CCT)
CCT intervention will consist of approximately 30 minutes of CCT games prior to each CBT session, to engage cognitive control capacity prior to receipt of CBT. The CCT games will be designed to target focused attention, response inhibition, working memory and multiple simultaneous attention to constitute a general executive function training, and activate neural systems associated with executive function/cognitive control. Difficulty of the games will be titrated individually and by session to avoid boredom and progressively activate the functional systems underlying cognitive control.
|
| Active Comparator: Cognitive behavioral therapy Participants will receive CBT sessions once a week for 12 weeks. |
Behavioral: Cognitive behavioral therapy (CBT)
The CBT intervention will consist of 12 weekly 60 minute sessions of the manualized therapy, adapted from the Coping Cat program, for the treatment of pediatric anxiety disorders.
|
Outcome Measures
Primary Outcome Measures
- Change in Brain activation and connectivity in the task-control network (TCN) [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 Outcome Measures
- Change in Pediatric Anxiety Rating Score (PARS) [Baseline, 12 weeks (after therapy)]
This is a 50 question interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The total scores on this scale range from 0 to 30, with scores above 13 indicating clinically meaningful anxiety.
- Change in behavioral performance on the conflict interference task and tasks testing cognitive control capacity included in the NIH Toolbox. [Baseline, 12 weeks (after therapy)]
Pre- to post-CBT changes in the behavioral performance in a conflict interference task, as well as, composite score from tasks included in the NIH toolbox
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Yanni Liu, Ph.D., University of Michigan
Study Documents (Full-Text)
More Information
Publications
None provided.- HUM00169730
- 5UL1TR002240-03