Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    54
  • sponsor
    University of Michigan
Updated on 2 August 2021
anxiety
behavior therapy
covid-19
cognitive therapy

Summary

This study will assign eighteen participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll thirty-six 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.

Details
Condition ANXIETY NEUROSIS, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, anxiety disorder
Treatment Cognitive behavioral therapy (CBT), Computerized Cognitive Training (CCT)
Clinical Study IdentifierNCT04157296
SponsorUniversity of Michigan
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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