Clinical trial NCT03592368: Hostile Interpretation Bias Training to Treat Irritability
Official title: Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Mood
Mood Disorders
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 97
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Interpretation Bias
timeFrame: Up to one day before and after the single 1 day training session of Interpretation bias training session.
measure: Neural Response in Threat Learning System.
timeFrame: During the course of the 1 day single session of interpretation bias training session.
Secondary outcomes:
measure: Learning Rate
timeFrame: During the course of the 1 day single interpretation bias training session.
measure: Irritability
timeFrame: Within one week prior to Interpretation bias training and one week +/- 3 days after Interpretation bias training.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Joel Stoddard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.