Across-subjects multiple baseline trial of exposure-based cognitive-behavioral therapy for severe irritability: a study protocol

Abstract

IntroductionIrritability is defined as a tendency towards anger in response to frustration. Clinically, impairing irritability is a significant public health problem. There is a need for mechanism-based psychotherapies targeting severe irritability as it manifests in the context of disruptive mood dysregulation disorder (DMDD). This study protocol describes a randomised multiple baseline design testing the preliminary efficacy of a new treatment, exposure-based cognitive-behavioral therapy for severe irritability in youth, which also integrates components of parent management training. We will investigate associations of this intervention with primary clinical measures, as well as ecological momentary assessment measures.Methods and analysisForty youth will be enrolled. Participants, aged 8–17 years, must present at least one of two core symptoms of DMDD: abnormal mood or increased reactivity to negative emotional stimuli, with severe impairment in one domain (home, school, peers) and moderate in another, or moderate impairment in at least two domains. Each participant is randomised to a 2-week, 4-week or 6-week baseline observation period, followed by 12 active treatment sessions. Clinical ratings are conducted at baseline, biweekly (clinician), weekly (parent/child) throughout treatment, post-treatment, and 3-month and 6-month follow-up (clinician). Clinician ratings on the Affective Reactivity Index and Clinical Global Impressions-Improvement scale for DMDD are our primary outcome measures. Secondary outcome measures include parent and child reports of irritability. Post hoc additional symptom measures include clinician, parent and self-ratings of depression, anxiety and overall functional impairment. Prospective, digitally based event sampling of symptoms is acquired for a week pre-treatment, mid-treatment and post-treatment. Based on our pathophysiological model of irritability implicating frustrative non-reward, aberrant threat processing and instrumental learning, we probe these three brain-based targets using functional MRI paradigms to assess target engagement.Ethics and disseminationThe research project and all related materials were submitted and approved by the appropriate Institutional Review Board (IRB) of the National Institute of Mental Health (NIMH).Trial registration numbersNCT02531893 and NCT00025935.

Associations of Sociodemographic Factors and Health Behaviors with the Emotional Well-Being of Adolescents during the COVID-19 Pandemic in Brazil

“…In Brazil, the most prevalent problem was irritability, with almost half of the participants reporting frequent irritability. It is interesting to note that irritability is defined as an emotional state that tends to lead to anger in response to frustration [47]. In the context of the COVID-19 pandemic, irritability is likely to reflect the frustration of not being able to enjoy routine and amusement activities.…”

Multiple needs and multiple treatments. What's a clinician to do? Update on the psychosocial treatment of disruptive behaviours in childhood

“…Recently developed treatments include the Unified Protocol for Transdiagnostic Treatment, CBT and integrated therapy with PMT [64][65][66][67][68]. Innovations in CBT targeting severe irritability, anger and aggression include behavioural exposure to frustrative nonrewarding and threatening stimuli [69]. Other treatments have expanded upon applications of emotion-coaching to improve child emotion regulation.…”

Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol

“…Despite this, treatments for irritability are limited. One promising treatment approach, based on our neurobiologically informed understanding of irritability, is exposure to anger-inducing events [ 73 ]. Preliminary evidence demonstrates the efficacy of exposure to anger-inducing events (as part of exposure-based cognitive behavioral therapy, CBT) as a treatment for irritability [ 69 ].…”

“…First, a substantial portion of youth do not sufficiently benefit from evidence-based treatments like CBT [ 26 ]. Furthermore, there is a paucity of CBT studies that target anger in youth from which to derive an understanding of clinical efficacy [ 31 , 48 , 69 , 73 , 94 ]. Approximately 22% to 50% of youth undergoing CBT for anxiety disorders or posttraumatic stress—both of which include irritability as a diagnostic symptom—do not respond or do not reach remission [ 46 , 51 , 57 , 79 , 88 ].…”