Hostile Interpretation Bias Training to Treat Irritability

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Irritable Mood; Mood Disorders

Treatments: Device: IBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03592368

17-0464

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 97 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 4 patient groups

Active IBT, Out of MRI

Active Comparator group

Description:

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.

Treatment:

Device: IBT

Sham IBT, Out of MRI

Sham Comparator group

Description:

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

Treatment:

Device: IBT

Active IBT, In MRI

Active Comparator group

Description:

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.

Treatment:

Device: IBT

Sham IBT, In MRI

Sham Comparator group

Description:

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

Treatment:

Device: IBT