N/A
N=21
Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04157296 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Change in Brain Activation and Connectivity in the Task-control Network (TCN) — 0.020; -0.206; 0.305; -0.004 Arbitrary Units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive behavioral therapy (CBT) (Behavioral); computerized cognitive training (CCT) (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brain Activation and Connectivity in the Task-control Network (TCN) |
0.020; -0.206; 0.305; -0.004; 0.082; -0.096 | — |
| SECONDARY Change in Pediatric Anxiety Rating Score (PARS) |
-5; -7.1 | 0.241 |
| SECONDARY Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times |
27.4; 70.7 | 0.233 |
| SECONDARY Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy |
-4.6; 9 | 0.042 sig |
| SECONDARY Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox |
-6.6; -8.4 | 0.349 |
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.
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
Data sourced from ClinicalTrials.gov (NCT04157296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.