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| ID | Type | Description | Link |
|---|---|---|---|
| 5UL1TR002240-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT and computerized cognitive training (CCT) | Experimental | 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). |
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| Cognitive behavioral therapy | Active Comparator | Participants will receive CBT sessions once a week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Activation and Connectivity in the Task-control Network (TCN) | 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. | Baseline, 12 weeks (after therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pediatric Anxiety Rating Score (PARS) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanni Liu, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Because this is a per-protocol analysis, the data from the 3 participants who did not complete the trial were not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy (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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Brain Activation and Connectivity in the Task-control Network (TCN) | 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. | One participant's fMRI data in the Cognitive Behavioral Therapy arm was not usable. | Posted | Mean | Standard Deviation | Arbitrary Units | Baseline, 12 weeks (after therapy) |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yanni Liu | University of Michigan | 734-936-9275 | yanniliu@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2021 | Nov 4, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2021 | Feb 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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A clinician, blind to whether patients are completing CCT or not, will deliver CBT to the patients.
| computerized cognitive training (CCT) | Behavioral | 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. |
|
| Baseline, 12 weeks (after therapy) |
| Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times | 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. | Baseline, 12 weeks (after therapy) |
| Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy | 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. | Baseline, 12 weeks (after therapy) |
| Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox | 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. | Baseline, 12 weeks (after therapy) |
| MRI failed/no second fMRI |
|
| BG001 | Cognitive Behavioral Therapy (CBT) | 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. |
| BG002 | Participants Who Did Not Complete | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Brain Activation and Connectivity in the Task-control Network (TCN) | 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. | Mean | Standard Deviation | Arbitrary Units |
|
| Pediatric Anxiety Rating Score (PARS) | 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. | Mean | Standard Deviation | Score on a Scale |
|
| Conflict Task Reaction Times | 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. | Mean | Standard Deviation | milliseconds |
|
| Conflict Task Accuracy | 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. | Mean | Standard Deviation | Percentage of correct responses |
|
| NIH Toolbox Composite Score | An app-based cognitive assessment of executive function, attention, memory, and language. The NIH toolbox standard score has a mean of 100 and standard deviation (SD) of 15. The higher the score, the better the performance. | Data for 2 participants in the Participants Who Did Not Complete arm was collected but was rendered unusable because of technical difficulties. | Mean | Standard Deviation | T-score |
|
| OG001 | 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. |
|
|
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| Secondary | Change in Pediatric Anxiety Rating Score (PARS) | 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 | Data for 2 participants in the "CBT and computerized cognitive training (CCT)" arm are missing. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks (after therapy) |
|
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|
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| Secondary | Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline, 12 weeks (after therapy) |
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| Secondary | Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy | 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. | Posted | Mean | Standard Deviation | percentage of correct responses | Baseline, 12 weeks (after therapy) |
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| Secondary | Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox | 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. | Posted | Mean | Standard Deviation | T-score | Baseline, 12 weeks (after therapy) |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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