Trial Outcomes & Findings for Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety (NCT NCT04157296)
NCT ID: NCT04157296
Last Updated: 2023-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline, 12 weeks (after therapy)
Results posted on
2023-02-01
Participant Flow
Participant milestones
| Measure |
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).
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.
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.
|
Cognitive Behavioral Therapy
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
15
|
|
Overall Study
COMPLETED
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
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).
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.
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.
|
Cognitive Behavioral Therapy
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Did not obtain second fMRI.
|
0
|
1
|
|
Overall Study
MRI failed/no second fMRI
|
0
|
1
|
Baseline Characteristics
During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT) and Computerized Cognitive Training (CCT)
n=6 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy (CBT)
n=12 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
Participants Who Did Not Complete
n=3 Participants
Participants who were assigned to the Cognitive behavioral therapy arm, but who withdrew or did not complete the trial. Data from the participants in this arm was not included in the outcome measure data.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 3.6 • n=6 Participants
|
12.4 years
STANDARD_DEVIATION 2.7 • n=12 Participants
|
10.2 years
STANDARD_DEVIATION 1.0 • n=3 Participants
|
12.6 years
STANDARD_DEVIATION 3.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
2 Participants
n=3 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
3 Participants
n=3 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial: black/white/native
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial: Bosniak
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial: Caucasian/Asian
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other: Pacific Islander
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
3 participants
n=3 Participants
|
21 participants
n=21 Participants
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
leftIFG
|
0.66 Arbitrary Units
STANDARD_DEVIATION 0.180 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.696 Arbitrary Units
STANDARD_DEVIATION 0.421 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.169 Arbitrary Units
STANDARD_DEVIATION 0.258 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.612 Arbitrary Units
STANDARD_DEVIATION 0.369 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
rightIFG
|
0.739 Arbitrary Units
STANDARD_DEVIATION 0.423 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.801 Arbitrary Units
STANDARD_DEVIATION .798 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.428 Arbitrary Units
STANDARD_DEVIATION 1.209 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.720 Arbitrary Units
STANDARD_DEVIATION 0.694 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
leftParietal
|
-0.002 Arbitrary Units
STANDARD_DEVIATION 0.586 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.066 Arbitrary Units
STANDARD_DEVIATION 0.576 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.659 Arbitrary Units
STANDARD_DEVIATION 0.064 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.058 Arbitrary Units
STANDARD_DEVIATION 0.591 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
rightParietal
|
1.037 Arbitrary Units
STANDARD_DEVIATION 0.356 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.679 Arbitrary Units
STANDARD_DEVIATION 0.605 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
1.038 Arbitrary Units
STANDARD_DEVIATION 1.296 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.791 Arbitrary Units
STANDARD_DEVIATION 0.614 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
leftdACC
|
0.876 Arbitrary Units
STANDARD_DEVIATION 0.310 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.681 Arbitrary Units
STANDARD_DEVIATION 0.418 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.607 Arbitrary Units
STANDARD_DEVIATION 0.664 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.705 Arbitrary Units
STANDARD_DEVIATION 0.410 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
rightdACC
|
0.997 Arbitrary Units
STANDARD_DEVIATION 0.489 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
1.026 Arbitrary Units
STANDARD_DEVIATION 0.719 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.678 Arbitrary Units
STANDARD_DEVIATION 0.720 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.971 Arbitrary Units
STANDARD_DEVIATION 0.612 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
leftInsula
|
0.535 Arbitrary Units
STANDARD_DEVIATION 0.099 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.438 Arbitrary Units
STANDARD_DEVIATION 0.379 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.086 Arbitrary Units
STANDARD_DEVIATION 0.345 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.416 Arbitrary Units
STANDARD_DEVIATION 0.325 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
rightInsula
|
0.73 Arbitrary Units
STANDARD_DEVIATION 0.289 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.573 Arbitrary Units
STANDARD_DEVIATION 0.41 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.433 Arbitrary Units
STANDARD_DEVIATION 1.141 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.571 Arbitrary Units
STANDARD_DEVIATION 0.463 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Brain Activation and Connectivity in the Task-control Network (TCN)
TCN
|
0.20 Arbitrary Units
STANDARD_DEVIATION 0.51 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.50 Arbitrary Units
STANDARD_DEVIATION 0.24 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
NA Arbitrary Units
STANDARD_DEVIATION NA • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
0.50 Arbitrary Units
STANDARD_DEVIATION 0.23 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable. Because only 2 participants' data in the "Participants Who Did Not Complete" arm could be analyzed, the number of participants was too few to calculate a TCN for this arm, as correlation analysis required 3 or more participants' data.
|
|
Pediatric Anxiety Rating Score (PARS)
|
12.5 Score on a Scale
STANDARD_DEVIATION 3.3 • n=6 Participants
|
19.2 Score on a Scale
STANDARD_DEVIATION 2.6 • n=12 Participants
|
17.7 Score on a Scale
STANDARD_DEVIATION 3.1 • n=3 Participants
|
17.4 Score on a Scale
STANDARD_DEVIATION 3.8 • n=21 Participants
|
|
Conflict Task Reaction Times
|
800.8 milliseconds
STANDARD_DEVIATION 365.5 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
885.9 milliseconds
STANDARD_DEVIATION 256.7 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
1164.2 milliseconds
STANDARD_DEVIATION 421.2 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
888.2 milliseconds
STANDARD_DEVIATION 305 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
|
Conflict Task Accuracy
|
91 Percentage of correct responses
STANDARD_DEVIATION 3 • n=6 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
86 Percentage of correct responses
STANDARD_DEVIATION 7 • n=12 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
92.2 Percentage of correct responses
STANDARD_DEVIATION 1 • n=2 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
88.3 Percentage of correct responses
STANDARD_DEVIATION 6 • n=20 Participants • During the fMRI scan, 1 participant in the "Participants Who Did Not Complete" arm moved too much. As a result, the participant's data was not usable.
|
|
NIH Toolbox Composite Score
|
111.2 T-score
STANDARD_DEVIATION 4.8 • n=6 Participants • Data for 2 participants in the Participants Who Did Not Complete arm was collected but was rendered unusable because of technical difficulties.
|
101.9 T-score
STANDARD_DEVIATION 11.4 • n=12 Participants • Data for 2 participants in the Participants Who Did Not Complete arm was collected but was rendered unusable because of technical difficulties.
|
106 T-score
n=1 Participants • Data for 2 participants in the Participants Who Did Not Complete arm was collected but was rendered unusable because of technical difficulties.
|
105.0 T-score
STANDARD_DEVIATION 10.2 • n=19 Participants • Data for 2 participants in the Participants Who Did Not Complete arm was collected but was rendered unusable because of technical difficulties.
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks (after therapy)Population: One participant's fMRI data in the Cognitive Behavioral Therapy arm was not usable.
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.
Outcome measures
| Measure |
CBT and Computerized Cognitive Training (CCT)
n=6 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy
n=11 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
leftdACC (Change in Brain activity [post minus pre])
|
-0.246 Arbitrary Units
Standard Deviation 0.26
|
0.164 Arbitrary Units
Standard Deviation 0.405
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
rightdACC (Change in Brain activity [post minus pre])
|
-0.203 Arbitrary Units
Standard Deviation 0.909
|
-0.270 Arbitrary Units
Standard Deviation 1.069
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
leftInsula (Change in Brain activity [post minus pre])
|
-0.221 Arbitrary Units
Standard Deviation 0.399
|
0.081 Arbitrary Units
Standard Deviation 0.388
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
rightInsula (Change in Brain activity [post minus pre])
|
-0.166 Arbitrary Units
Standard Deviation 0.541
|
0.067 Arbitrary Units
Standard Deviation 0.702
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
TCN (Change in Connectivity [post minus pre])
|
0.20 Arbitrary Units
Standard Deviation 0.47
|
0.53 Arbitrary Units
Standard Deviation 0.26
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
leftIFG (Change in Brain activity [post minus pre])
|
0.020 Arbitrary Units
Standard Deviation 0.151
|
-0.206 Arbitrary Units
Standard Deviation 0.561
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
rightIFG (Change in Brain activity [post minus pre])
|
0.305 Arbitrary Units
Standard Deviation 0.742
|
-0.004 Arbitrary Units
Standard Deviation 0.653
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
leftParietal (Change in Brain activity [post minus pre])
|
0.082 Arbitrary Units
Standard Deviation 0.095
|
-0.096 Arbitrary Units
Standard Deviation 0.559
|
|
Change in Brain Activation and Connectivity in the Task-control Network (TCN)
rightParietal (Change in Brain activity [post minus pre])
|
-0.356 Arbitrary Units
Standard Deviation 0.375
|
-0.032 Arbitrary Units
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks (after therapy)Population: Data for 2 participants in the "CBT and computerized cognitive training (CCT)" arm are missing.
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. The numbers presented represent the value at 12 weeks minus the value at baseline
Outcome measures
| Measure |
CBT and Computerized Cognitive Training (CCT)
n=4 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy
n=12 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Change in Pediatric Anxiety Rating Score (PARS)
|
-5 score on a scale
Standard Deviation 6.8
|
-7.1 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks (after therapy)Pre- to post-CBT changes in the behavioral performance in a conflict interference task. The time for the task at 12 weeks minus at baseline yields a number whose absolute value of change is shown below. Thus, when assessing the change, the higher number corresponds to more improvement in reaction time.
Outcome measures
| Measure |
CBT and Computerized Cognitive Training (CCT)
n=6 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy
n=12 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times
|
27.4 milliseconds
Standard Deviation 55.3
|
70.7 milliseconds
Standard Deviation 135
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks (after therapy)Pre- to post-CBT changes in the behavioral performance in a conflict interference task. Conflict interference task refers to a task assigned to a participant to complete that also includes some form of distraction or condition that interferes with completion of the task. For this, the lower number indicates more improvement in accuracy in competing the task.
Outcome measures
| Measure |
CBT and Computerized Cognitive Training (CCT)
n=6 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy
n=12 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy
|
-4.6 percentage of correct responses
Standard Deviation 3.6
|
9 percentage of correct responses
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks (after therapy)Pre- to post-CBT changes in the NIH toolbox composite score from the cognitive control module included in the toolbox. The NIH toolbox standard score has a mean of 100 and standard deviation (SD) of 15. The lower the change in the score between the pre- and the post-CBT changes indicates the higher degree of improvement.
Outcome measures
| Measure |
CBT and Computerized Cognitive Training (CCT)
n=6 Participants
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).
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.
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.
|
Cognitive Behavioral Therapy
n=12 Participants
Participants will receive CBT sessions once a week for 12 weeks.
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.
|
|---|---|---|
|
Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox
|
-6.6 T-score
Standard Deviation 10.7
|
-8.4 T-score
Standard Deviation 7.8
|
Adverse Events
CBT and Computerized Cognitive Training (CCT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place