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Hostile Interpretation Bias Training to Treat Irritability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592368
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Mood Mood Disorders Device: IBT Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active IBT, Out of MRI Device: IBT
Interpretation bias training
Sham Comparator: Sham IBT, Out of MRI Device: IBT
Interpretation bias training
Active Comparator: Active IBT, In MRI Device: IBT
Interpretation bias training
Sham Comparator: Sham IBT, In MRI Device: IBT
Interpretation bias training


Outcome Measures
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Primary Outcome Measures :
  1. Change in Interpretation Bias [ Time Frame: Up to one day before and after the single 1 day training session of Interpretation bias training session. ]
    Interpretation bias is measured by the indifference point of happy-angry judgments of a continuum of morphed images between happy=1 to angry=15 facial expressions. Lower indifference points indicate a higher bias towards hostile (or angry) judgments. Change in interpretation bias is the difference between the post- and pre-IBT indifference points.

  2. Neural response in threat learning system. [ Time Frame: During the course of the 1 day single session of interpretation bias training session. ]
    Amygdala functional connectivity to ventromedial prefrontal cortex is measured by covariance in fluctuations in blood oxygen-level dependent signal between these regions during functional magnetic resonance imaging during the course of training. These fluctuations are expected to be significantly modulated by interpretation bias training.


Secondary Outcome Measures :
  1. Learning Rate [ Time Frame: During the course of the 1 day single interpretation bias training session. ]
    Learning rate as measured by a reinforcement learning computational model during IBT. It measures the average trial-by-trial change in happy or angry judgments in response to feedback during a session of IBT.

  2. Irritability [ Time Frame: Within one week prior to Interpretation bias training and one week +/- 3 days after Interpretation bias training. ]
    Tendency towards anger and temper outburst as measured by the Affective Reactivity Index.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592368


Contacts
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Contact: Joel Stoddard, MD 720-777-5702 joel.stoddard@ucdenver.edu

Locations
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United States, Colorado
University of Colorado, School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Joel Stoddard, MD    720-777-5702    joel.stoddard@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Joel Stoddard, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] July 12, 2019

More Information
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Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03592368    
Other Study ID Numbers: 17-0464
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A commitment to data sharing and analytic code has been made. Specifics of the data sharing plan require further work due to the collection of protected health information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Mood Disorders
Mental Disorders