Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Cognitive behavioral therapy (CBT); Behavioral: computerized cognitive training (CCT)

• Registration Number: NCT04157296
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Study Start: 2020-02-04
• Primary Completion: 2021-11-07
• Study Completion: 2021-11-12
• Results First Submitted: 2022-11-07
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Results First Posted: 2023-02-01
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Read More

Exclusion Criteria

• Color blindness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT and computerized cognitive training (CCT)	Cognitive behavioral therapy (CBT)	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	Cognitive behavioral therapy (CBT)	Participants will receive CBT sessions once a week for 12 weeks.
CBT and computerized cognitive training (CCT)	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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. The numbers presented represent the value at 12 weeks minus the value at baseline
Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox	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.
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times	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.
Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States