Hostile Interpretation Bias Training to Treat Irritability

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2023-01-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Mood Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active IBT, Out of MRI

Interpretation bias training where participants learn more positive judgements of ambiguous facial expressions relative to their own baseline bias. This arm is completed in the clinic.

Group Type ACTIVE_COMPARATOR

IBT

Intervention Type DEVICE

Interpretation bias training

Sham IBT, Out of MRI

Interpretation bias training where participants' baseline judgements of ambiguous facial expressions is reinforced. This arm is completed in the clinic.

Group Type SHAM_COMPARATOR

IBT

Intervention Type DEVICE

Interpretation bias training

Active IBT, In MRI

Interpretation bias training where participants learn more positive judgements of ambiguous facial expressions relative to their own baseline judgments. This arm is completed in a magnetic resonance imaging machine.

Group Type ACTIVE_COMPARATOR

IBT

Intervention Type DEVICE

Interpretation bias training

Sham IBT, In MRI

Interpretation bias training where participants' baseline judgements of ambiguous facial expressions is reinforced. This arm is completed in a magnetic resonance imaging machine.

Group Type SHAM_COMPARATOR

IBT

Intervention Type DEVICE

Interpretation bias training

Interventions

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IBT

Interpretation bias training

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adolescents in mental health treatment, with at least:

1. mild, clinically significant irritability, and
2. typical intellectual functioning (IQ\>80)

Exclusion Criteria

* Any of the following mental health diagnoses:

1. current post-traumatic stress
2. lifetime bipolar I or II disorder
3. lifetime cyclothymic disorder
4. lifetime psychotic disorder
5. lifetime autism spectrum disorder
* Major medical problems, including head trauma.
* MRI-specific safety exclusions for the MRI arms.
* Clinical instability.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No