Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety

NCT04157296 | Completed Results

• 2 other identifiers: HUM001697305UL1TR002240-03
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

anxious; Cognitive behavioral therapy; Computerized cognitive training

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 12 weeks (after therapy)

Secondary Outcomes (4)

• Change in Pediatric Anxiety Rating Score (PARS)

  Baseline, 12 weeks (after therapy)

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

  Baseline, 12 weeks (after therapy)

• Change in Behavioral Performance on the Conflict Interference Task- Conflict Task Accuracy

  Baseline, 12 weeks (after therapy)

• Change in Tasks Testing Cognitive Control Capacity Included in the NIH Toolbox

  Baseline, 12 weeks (after therapy)

Study Arms (2)

CBT and computerized cognitive training (CCT)

EXPERIMENTAL

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).

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

Cognitive behavioral therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

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.

CBT and computerized cognitive training (CCT); Cognitive behavioral therapy

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.

CBT and computerized cognitive training (CCT)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Color blindness

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Yanni Liu
• Organization: University of Michigan

yanniliu@med.umich.edu

734-936-9275

Study Officials

• Yanni Liu, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A clinician, blind to whether patients are completing CCT or not, will deliver CBT to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: February 4, 2020
• Primary Completion: November 7, 2021
• Study Completion: November 12, 2021
• Last Updated: February 1, 2023
• Results First Posted: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)