Irritable MoodNCT03592368
Hostile Interpretation Bias Training to Treat Irritability
A study testing IBT in people with Irritable Mood and Mood Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Irritable Mood, Mood Disorders
- What is being tested?
- IBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 27 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents in mental health treatment, with at least:
- mild, clinically significant irritability, and
- typical intellectual functioning (IQ>80)
Who cannot join
- 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
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- Major medical problems, including head trauma.
- MRI-specific safety exclusions for the MRI arms.
- Clinical instability.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, School of Medicine
Aurora, Colorado, 80045
About this study
Official title: Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability
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.
Read the 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.
- Conditions
- Irritable Mood, Mood Disorders
- Being tested
- IBT
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBTDevice
Interpretation bias training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: IBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the course of the 1 day single session of interpretation bias training session.
Secondary outcomes (2)
Learning Rate
Learning rate as measured by a reinforcement learning computational model during IBT, please see the reference Stoddard et al., 2023, for model details. As in general reinforcement learning models, it is the proportion of prediction error that is applied to future expectations. In this trial, when a participant received feedback about a judgement they made of a face, the participant implicitly compares that feedback to their expectations about that face. The difference between the feedback and their expectations is called prediction error. The learning rate the proportion of this prediction error that is applied to future expectations across the learning session. In that way it represents learning. Learning rate is a continuous, unitless value. It ranges from 0, representing no learning, to 1, representing perfect learning. It is generally small. The learning rate reported here is its form estimated across face emotions (see Stoddard et al., 2023).
Measured: During the course of the 1 day single interpretation bias training session.
Irritability
Irritability is the tendency towards anger and temper outburst as measured by the Affective Reactivity Index, a seven item scale. Each item has 3 response options which are coded as follows: "not true"=0, "somewhat true"=1, and "certainly true"=2. The first six items are summed to generate a total score that reflects the degree over irritability over the past week. The Affective Reactivity Index ranges from 0 to 12. Higher values reflect more irritability. What is reported here is the average post- minus pre-treatment score, by parent report. In these differences, negative values are in the unit of this scale and the absolute value represents the degree of irritability reduction.
Measured: Within one week prior to Interpretation bias training and one week +/- 3 days after Interpretation bias training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Oct 2018
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable MoodStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Stoddard, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592368
- Sponsor's protocol ID
- 17-0464
- Status last verified
- Mar 2024
- First submitted
- 26 Jun 2018
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26745832Haller 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.
PubMed 34147585Stoddard 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.
PubMed 37062362