TY - JOUR
T1 - A double-blind, randomized, placebo-controlled trial of a computer-based Interpretation Bias Training for youth with severe irritability
T2 - A study protocol
AU - Haller, Simone P.
AU - Stoddard, Joel
AU - MacGillivray, Caroline
AU - Stiles, Kelsey
AU - Perhamus, Gretchen
AU - Penton-Voak, Ian S.
AU - Bar-Haim, Yair
AU - Munafò, Marcus R.
AU - Brotman, Melissa A.
N1 - Publisher Copyright:
© 2018 The Author(s).
PY - 2018/11/14
Y1 - 2018/11/14
N2 - Background: Severe, 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/design: This 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. Discussion: The 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 registration: ClinicalTrials.gov, ID: NCT02531893. Registered on 25 August 2015.
AB - Background: Severe, 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/design: This 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. Discussion: The 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 registration: ClinicalTrials.gov, ID: NCT02531893. Registered on 25 August 2015.
KW - Children and adolescence
KW - Cognitive training
KW - DMDD
KW - Face-emotion
KW - Interpretation bias
KW - Irritability
KW - RCT
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85056610073&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2960-5
DO - 10.1186/s13063-018-2960-5
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AN - SCOPUS:85056610073
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 626
ER -