Clinical trial NCT04157296: Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety
Official title: Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: anxious
Cognitive behavioral therapy
Computerized cognitive training
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-11-08
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Brain Activation and Connectivity in the Task-control Network (TCN)
timeFrame: Baseline, 12 weeks (after therapy)
Secondary outcomes:
measure: Change in Pediatric Anxiety Rating Score (PARS)
timeFrame: Baseline, 12 weeks (after therapy)
measure: Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Reaction Times
timeFrame: Baseline, 12 weeks (after therapy)
measure: Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy
timeFrame: Baseline, 12 weeks (after therapy)
measure: Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox
timeFrame: Baseline, 12 weeks (after therapy)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yanni Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: