Hostile Interpretation Bias Training to Treat Irritability

NCT03592368 | Completed Results DMC FDA Device

• 1 other identifier: 17-0464
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Mood; Mood Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Interpretation Bias

  Interpretation bias is measured by the indifference point of happy-angry judgments of a continuum of 15 images of face emotion expression that are morphed between completely happy=1 to completely angry=15 facial expressions. Indifference point is represented on this scale of 1 to 15 faces. It represents the point on the face continuum where judgements change from predominantly happy to predominantly angry. Indifference points have a minimum value of 1 and a maximum value of 15, though are typically in the middle of the face-emotion continuum, e.g. 7. Lower indifference points represent a higher bias towards hostile (or angry) judgments. Change in interpretation bias is the difference between the post- and pre-training indifference points. This can range from -14 to 14, with positive numbers reflecting the degree to which the happy/angry decision bias is shifted towards more happy judgements. High positive numbers reflect a greater increase in happy judgments.

  Up to one day before and after the single 1 day training session of Interpretation bias training session.

• Neural Response in Threat Learning System.

  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 (fMRI) during the course of training. The outcome measure is a count of these randomized participants for whom the fMRI measure is valid for the planned connectivity analysis. These participants completed the task in scanner with acceptable behavioral data and fMRI data. Quality control for fMRI included visual inspection of brain images for quality, coverage, and proper alignment across functional, anatomic and template images. The fMRI images passed analysis benchmarks of \<20% censored volumes and \<0.25 mm Euclidean distance average censored motion across the task. Censor thresholds are 0.3 mm Euclidean distance and 5% voxels with outlying intensity values.

  During the course of the 1 day single session of interpretation bias training session.

Secondary Outcomes (2)

• Learning Rate

  During the course of the 1 day single interpretation bias training session.

• Irritability

  Within one week prior to Interpretation bias training and one week +/- 3 days after Interpretation bias training.

Study Arms (4)

Active IBT, Out of MRI

ACTIVE COMPARATOR

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.

Device: IBT

Sham IBT, Out of MRI

SHAM COMPARATOR

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

Device: IBT

Active IBT, In MRI

ACTIVE COMPARATOR

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.

Device: IBT

Sham IBT, In MRI

SHAM COMPARATOR

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

Device: IBT

Interventions

IBT DEVICE

Interpretation bias training

Active IBT, In MRI; Active IBT, Out of MRI; Sham IBT, In MRI; Sham IBT, Out of MRI

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents in mental health treatment, with at least:
• mild, clinically significant irritability, and
• typical intellectual functioning (IQ\>80)

You may not qualify if:

• 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.
• Clinical instability.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, School of Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Stoddard J, Sharif-Askary B, Harkins EA, Frank HR, Brotman MA, Penton-Voak IS, Maoz K, Bar-Haim Y, Munafo M, Pine DS, Leibenluft E. An Open Pilot Study of Training Hostile Interpretation Bias to Treat Disruptive Mood Dysregulation Disorder. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):49-57. doi: 10.1089/cap.2015.0100. Epub 2016 Jan 8.

  PMID: 26745832 BACKGROUND

• Haller SP, Stoddard J, Botz-Zapp C, Clayton M, MacGillivray C, Perhamus G, Stiles K, Kircanski K, Penton-Voak IS, Bar-Haim Y, Munafo M, Towbin KE, Brotman MA. A Randomized Controlled Trial of Computerized Interpretation Bias Training for Disruptive Mood Dysregulation Disorder: A Fast-Fail Study. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):37-45. doi: 10.1016/j.jaac.2021.05.022. Epub 2021 Jun 17.

  PMID: 34147585 BACKGROUND

• Stoddard J, Haller SP, Costa V, Brotman MA, Jones M. A Computational Model Reveals Learning Dynamics During Interpretation Bias Training With Clinical Applications. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Oct;8(10):1033-1040. doi: 10.1016/j.bpsc.2023.03.013. Epub 2023 Apr 14.

  PMID: 37062362 BACKGROUND

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Joel Stoddard
• Organization: University of Colorado, Anschutz Medical Campus

joel.stoddard@cuanschutz.edu

(720) 777-5702

Study Officials

• Joel Stoddard, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 19, 2018
• Study Start: October 15, 2018
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)