Anger Self-Management in Post-Acute Traumatic Brain Injury: Clinic Trial

描述（由申请人提供）：在创伤性脑损伤（TBI）后，在各种损伤严重程度范围内，问题性愤怒和易怒是常见且持续的。愤怒症状对情绪健康、社区生活、家庭和社会关系有负面影响。TBI后的问题性愤怒有许多原因，包括有机和非有机或损伤的继发性影响。执行功能的特征性缺陷，例如自我监控和解决问题的缺陷，也起作用。可用的治疗方法包括药物治疗，行为矫正和认知行为干预，但很少有适应社区居住的TBI患者的需求，也很少进行治疗试验。本研究是一项II期临床试验，旨在测试一种名为愤怒自我管理训练（ASMT）的新型治疗方法的价值，与提供教育和心理支持（EPS）的对照治疗相比，治疗师时间和治疗结构相当。ASMT是一个基于自我监控和解决问题训练原则的8节个人心理教育干预课程。ASMT的一项单中心试点研究显示，从治疗前到治疗后，愤怒和愤怒表达的标准化测量值有所改善;本试验的目的是在更大，更多样化的样本中将其与EPS进行比较。患有问题性愤怒的参与者，在复杂的轻度、中度或重度TBI后至少6个月，以及重要的其他（SO）（如果可用），将以2：1的比例随机分配至ASMT或EPS。治疗前至治疗后对自我报告愤怒测量的治疗反应将作为主要结局。将从3家临床试验机构共入组99例受试者。次要结果包括治疗反应的轨迹和持续性; SO报告的参与者愤怒的变化;情绪和行为状态;以及生活质量。将检查受试者的特征与治疗反应的相关性。如果试验证明了ASMT进一步研究的价值，这种治疗模式最终可能提供一种易于传播的方法，TBI患者可以通过这种方法学会重新获得对有问题的愤怒/易怒的个人控制。

DESCRIPTION (provided by applicant): Problematic anger and irritability are common and persistent after traumatic brain injury (TBI) across the spectrum of injury severity. Anger symptoms have negative effects on emotional well-being, community living, and family and social relationships. Problematic anger after TBI has numerous causes including organic and non-organic or secondary effects of injury. Characteristic deficits in executive function, e.g. impaired self-monitoring and problem-solving deficits, also play a role. Available treatments include medications, behavior modification, and cognitive-behavioral interventions, but few have been adapted to the needs of community dwelling persons with TBI and few treatment trials have been conducted. The present study is a Phase II clinical trial designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a control treatment offering education and psychological support (EPS) with equivalent therapist time and therapeutic structure. The ASMT is an 8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training. A single-center pilot study of the ASMT showed improvement on standardized measures of anger and anger expression from pre to post treatment; the purpose of the present trial is to compare it to EPS in a larger, more diverse sample. Participants with problematic anger who are at least 6 months post complicated mild, moderate or severe TBI, and a Significant Other (SO), if available, will be randomized 2:1 to ASMT or EPS. Treatment response on measures of self-reported anger pre- to post-treatment will serve as the primary outcome. A total of 99 participants will be enrolled from 3 clinical sites. Secondary outcomes include trajectory and persistence of treatment response; change in SO-reported participant anger; emotional and behavioral status; and quality of life. Characteristics of participants will be examined for their association to treatment response. If the trial demonstrates the value of further study of the ASMT, this treatment model may eventually offer a readily disseminable method by which people with TBI can learn to regain personal control over problematic anger/ irritability.