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

Abstract

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://ichgcp.net/clinical-trials-registry/NCT02531893" title="See in ClinicalTrials.gov">NCT02531893.

Trial registration: ClinicalTrials.gov NCT02531893 NCT00025935.

Keywords: RCT; cognitive bias; face-emotion labeling; irritability.

Conflict of interest statement

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.

Figures

Figure 1.. Interpretation Bias Training (IBT)

Note: (A) Illustration of a training trial. (B) Active IBT was designed to shift the balance point two morphs along the continuum of face-morphs. Hence, by the end of the training session, participants were expected to rate two ambiguous morphs as happy that were rated angry pre-treatment. Sham IBT provided feedback consistent with the pre-training balance point.

Figure 2.. Balance Point by Training Group and Session

Note: Error bars show standard error.

Figure 3.. Irritability Outcome Measures

Note: (A) Clinician- and (B) parent-rated irritability by group and session. (C) Improvement scores relative to baseline by group (active vs sham interpretation bias training [IBT]) and session (post-training and 1- and 2-weeks following training; 5 = No Improvement). Right panel: Error bars show standard error.