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Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability

Primary Objective

Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability. This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Study category: Behaviors and Mental Health

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Description

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Details
Age

Child

Eligibility

Inclusion Criteria: Adolescents ages 13 to 17 years in mental health treatment, with at least: * mild, clinically significant irritability, and * typical intellectual functioning (IQ>80)

Detailed Eligibility: Exclusion Criteria: Any of the following mental health diagnoses: current post-traumatic stress lifetime bipolar I or II disorder lifetime cyclothymic disorder lifetime psychotic disorder lifetime autism spectrum disorder Major medical problems, including head trauma. MRI-specific safety exclusions for the MRI arms. Clinical instability.

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Device Feasibility

Scope

Local

Location

Childrens Hospital Colorado

Principal Investigator
Joel Stoddard

Joel Stoddard

Study ID

Protocol Number: 17-0464

ClinicalTrials.gov: NCT03592368

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