Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA
Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.
BMJ Open. 2021 Mar 10;11(3):e039169. doi: 10.1136/bmjopen-2020-039169.
Irritability 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.
Forty 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.
The 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).
NCT02531893 and NCT00025935.
易激惹被定义为对挫折产生愤怒的倾向。临床上，易激惹受损是一个严重的公共健康问题。由于破坏性心境失调障碍（DMDD）患者的易激惹表现出明显的病理机制，因此需要针对严重易激惹的基于机制的心理治疗。本研究方案描述了一项随机多项基线设计，旨在测试一种新的治疗方法——针对青少年严重易激惹的暴露性认知行为治疗的初步疗效，该方法还整合了家长管理培训的内容。我们将调查该干预措施与主要临床指标以及生态瞬时评估指标的关联。
将招募 40 名 8-17 岁的青少年参与者。参与者必须出现 DMDD 的至少两种核心症状之一：异常情绪或对负性情绪刺激的反应性增加，且在一个领域（家庭、学校、同伴）严重受损，另一个领域中度受损，或至少两个领域中度受损。每位参与者被随机分配到为期 2 周、4 周或 6 周的基线观察期，随后进行 12 次主动治疗。在基线、双周（临床医生）、每周（父母/孩子）进行临床评估，直至治疗结束后、3 个月和 6 个月随访（临床医生）。DMDD 的临床医生评估采用情感反应指数和临床总体印象改善量表作为主要疗效指标。次要疗效指标包括父母和孩子对易激惹的报告。事后附加症状指标包括临床医生、父母和孩子对抑郁、焦虑和总体功能障碍的评估。在治疗前、治疗中和治疗后一周内进行前瞻性、基于数字的症状事件抽样。根据我们关于易激惹的病理生理学模型，涉及挫折性非奖励、异常威胁处理和工具性学习，我们使用功能磁共振成像范式探查这三个大脑目标，以评估目标的参与度。
研究项目及所有相关材料均已提交并获得国家心理健康研究所（NIMH）适当机构审查委员会（IRB）的批准。
NCT02531893 和 NCT00025935。
