Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

University of Michigan

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: computerized cognitive training (CCT); Behavioral: Cognitive behavioral therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04157296

HUM00169730

5UL1TR002240-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

CBT and computerized cognitive training (CCT)

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive behavioral therapy (CBT)

Behavioral: computerized cognitive training (CCT)

Cognitive behavioral therapy

Active Comparator group

Description:

Participants will receive CBT sessions once a week for 12 weeks.

Treatment:

Behavioral: Cognitive behavioral therapy (CBT)