New research
A Randomized Controlled Trial of Computerized Interpretation Bias Training for Disruptive Mood Dysregulation Disorder: A Fast-Fail Study

https://doi.org/10.1016/j.jaac.2021.05.022Get rights and content
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Objective

To examine targeted, mechanism-based interventions is the next generation of treatment innovation. Biased threat labeling of ambiguous face emotions (interpretation bias) is a potential behavioral treatment target for anger, aggression, and irritability. Changing biases in face-emotion labeling may improve irritability-related outcomes. Here, we report the first randomized, double-blind, placebo-controlled targeted trial of interpretation bias training (IBT) in youths with chronic, severe irritability.

Method

Patients with current disruptive mood dysregulation disorder (DMDD; N = 44) were randomly assigned to complete 4 sessions of active (n = 22) or sham (n = 22) computerized IBT training within a 1-week period. The first and last trainings were completed onsite, and 2 trainings were completed at home. We examined the effects of active IBT on labeling bias, primary outcome measures of irritability, and secondary outcome measures of anxiety, depression, and functional impairment. Follow-up assessments were completed immediately after the intervention as well as 1 and 2 weeks later.

Results

We found that active IBT engaged the behavioral target in the active relative to the sham condition, as shown by a significant shift toward labeling ambiguous faces as happy. However, there was no consistent clinical improvement in active IBT relative to the sham condition either immediately after or 2 weeks after training in either the primary or secondary outcome measures.

Conclusion

Although this randomized controlled trial of IBT in youths with DMDD engaged the proposed behavioral target, there was no statistically significant improvement on clinical outcome. Identifying and changing behavioral targets is a first step in novel treatment development; these results have broader implications for target-based intervention development.

Clinical trial registration information

Psychological Treatments for Youth With Severe Irritability; https://clinicaltrials.gov/; NCT02531893.

Key words

RCT
face-emotion labeling
cognitive bias
irritability

Cited by (0)

This research was supported by the Intramural Research Program of the National Institute of Mental Health (NIMH), National Institutes of Health (NIH; ZIAMH002778-17 and ZIAMH002786-15) and was conducted under NIH Clinical Study Protocols 15-M-0182 and 02-M-0021 (ClinicalTrials.gov ID: NCT02531893 and NCT00025935). J.S. was supported by a grant from NIH, NIMH, (K23MH113731) and the Pediatric Mental Health Institute at Children’s Hospital Colorado and the Division of Child and Adolescent Psychiatry, Department of Psychiatry, University of Colorado School of Medicine. The funding source was not involved in study design; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication. M.M. and I.P.-V. are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at University Hospitals Bristol National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed in this publication are those of the author(s) and not necessarily those of NHS, NIHR, or the Department of Health and Social Care.

Author Contributions

Conceptualization: Stoddard, Penton-Voak, Bar-Haim, Munafò, Towbin, Brotman

Data curation: Haller, Stoddard, Botz-Zapp, Clayton, MacGillivray, Perhamus, Stiles

Formal analysis: Haller, Stoddard, Brotman

Funding acquisition: Brotman

Investigation: Kircanski, Bar-Haim

Methodology: Brotman

Project administration: Haller, Botz-Zapp, Clayton, MacGillivray, Perhamus, Stiles, Kircanski, Towbin, Brotman

Resources: Kircanski, Towbin

Software: Haller, Stoddard, Penton-Voak, Munafò

Supervision: Kircanski, Bar-Haim, Munafò, Towbin, Brotman

Validation: Haller

Visualization: Haller

Writing – original draft: Haller

Writing – review and editing: Stoddard, Botz-Zapp, Clayton, MacGillivray, Perhamus, Stiles, Kircanski, Penton-Voak, Bar-Haim, Munafò, Towbin, Brotman

Disclosure: Dr. Haller has received grant support through a Brain and Behavior Research Foundation (BBRF) Young Investigator Award. Dr. Stoddard has received grant or research support from NIMH. He has served as a DSMB committee member: Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety (R61 Phase). Drs. Penton-Voak and Munafò are co-directors of Jericoe Ltd., a company that licenses software for the assessment and modification of emotion recognition. Dr. Bar-Haim has received grant or research support from the Israel Science Foundation and the US Department of Defense. Dr. Brotman has served as a principal investigator (PI) on a Bench-to-Bedside grant from NIH. Drs. Kircanski and Towbin, Mr. Botz-Zapp, and Mss. Clayton, MacGillivray, Perhamus, and Stiles have reported no biomedical financial interests or potential conflicts of interest.

Published by Elsevier Inc. on behalf of the American Academy of Child and Adolescent Psychiatry.