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OpenTrials
Completed

NCT Number: NCT04157296

Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

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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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Brain Activation and Connectivity in the Task-control Network (TCN)

    Time frame: 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 outcomes

  1. Change in Pediatric Anxiety Rating Score (PARS)

    Time frame: 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

  2. Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times

    Time frame: 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.

  3. Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy

    Time frame: 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.

  4. Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2019
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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