Abstract
BackgroundSevere, chronic, and impairing irritability is a common presenting clinical problem in youth. Indeed, it was recently operationalized as disruptive mood dysregulation disorder (DMDD) in the DSM-5. However, to date, there are no evidence-based treatments that were specifically developed for DMDD. The current randomized controlled trial assesses the efficacy of a computer-based cognitive training intervention (Interpretation Bias Training; IBT) in youth with DMDD. IBT aims to reduce irritability by altering judgments of ambiguous face-emotions through computerized feedback. IBT is based on previous findings that youth with irritability-related psychopathology rate ambiguous faces as more hostile and fear producing.Methods/designThis is a double-blind, randomized controlled trial of IBT in 40 youth with DMDD. Participants will be randomized to receive four IBT sessions (Active vs. Sham training) over 4 days. Active IBT provides computerized feedback to change ambiguous face-emotion interpretations towards happy interpretations. Face-emotion judgments are performed pre and post training, and for 2 weeks following training. Blinded clinicians will conduct weekly clinical ratings. Primary outcome measures assess changes in irritability using the clinician-rated Affective Reactivity Index (ARI) and Clinical Global Impressions-Improvement (CGI-I) scale for DMDD, as well as parent and child reports of irritability using the ARI. Secondary outcome measures include clinician ratings of depression, anxiety, and overall impairment. In addition, parent and child self-report measures of depression, anxiety, anger, social status, and aggression will be collected.DiscussionThe study described in this protocol will perform the first RCT testing the efficacy of IBT in reducing irritability in youth with DMDD. Developing non-pharmacological treatment options for youth suffering from severe, chronic irritability is important to potentially augment existing treatments.Trial registrationClinicalTrials.gov, ID: NCT02531893. Registered on 25 August 2015.
Highlights
Severe, chronic, and impairing irritability is a common presenting clinical problem in youth
The study described in this protocol will perform the first randomized controlled trial (RCT) testing the efficacy of Interpretation Bias Training (IBT) in reducing irritability in youth with disruptive mood dysregulation disorder (DMDD)
In a randomized controlled trial (RCT) of 46 adolescents who were in residential treatment because of aggressive behavior and high-risk of criminal behavior, Penton-Voak et al [24] reported that four sessions of Active compared to Sham training on the IBT task shifted participants’ balance point” (BP) toward happy and away from angry judgments
Summary
This study is the first RCT of IBT in youth with DMDD. Chronic irritability, such as observed in DMDD, is severe and impairing for affected youth and their families, yet available treatment options are limited (Brotman et al, 2017). The current protocol describes the first double-blind RCT aimed to test the efficacy of IBT in reducing irritability in youth with DMDD. Primary outcome measures assess changes in irritability pre to post training and 2 weeks after training using the clinician ARI and CGI-I for DMDD, as well as parent- and child-reports of irritability using the ARI. Parent- and child self-report measures of depression, anxiety, anger, social status, and aggression are collected. In this RCT, IBT is an augmentation to stable community treatment (pharmacological and/or psychosocial). Trial status The protocol (15-M-0182, Psychological Treatments for Youth with Severe Irritability) received final IRB approval in August 2015, after which trial recruitment commenced.
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