Adults 7 to 17, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Brain Activation and Connectivity in the Task-control Network (TCN)Primary· 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.
leftIFG (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
0.020
± 0.151
Cognitive Behavioral Therapy
-0.206
± 0.561
rightIFG (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
0.305
± 0.742
Cognitive Behavioral Therapy
-0.004
± 0.653
leftParietal (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
0.082
± 0.095
Cognitive Behavioral Therapy
-0.096
± 0.559
rightParietal (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-0.356
± 0.375
Cognitive Behavioral Therapy
-0.032
± 0.66
leftdACC (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-0.246
± 0.26
Cognitive Behavioral Therapy
0.164
± 0.405
rightdACC (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-0.203
± 0.909
Cognitive Behavioral Therapy
-0.270
± 1.069
leftInsula (Change in Brain activity [post minus pre])
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-0.221
± 0.399
Cognitive Behavioral Therapy
0.081
± 0.388
rightInsula (Change in Brain activity [post minus pre])
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
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-5
± 6.8
Cognitive Behavioral Therapy
-7.1
± 4.4
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction TimesSecondary· 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.
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
27.4
± 55.3
Cognitive Behavioral Therapy
70.7
± 135
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task AccuracySecondary· 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.
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-4.6
± 3.6
Cognitive Behavioral Therapy
9
± 6.8
Change in Tasks Testing Cognitive Control Capacity Included in the NIH ToolboxSecondary· 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.
Group
Value
95% CI
CBT and Computerized Cognitive Training (CCT)
-6.6
± 10.7
Cognitive Behavioral Therapy
-8.4
± 7.8
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 1 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157296.