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，在不同程度的损伤中，有问题的愤怒和烦躁是常见且持续存在的。愤怒症状对情绪健康、社区生活以及家庭和社会关系产生负面影响。 TBI 后出现问题性愤怒有多种原因，包括器质性和非器质性或伤害的继发影响。执行功能的特征性缺陷，例如自我监控能力受损和解决问题能力不足也起到了一定作用。可用的治疗方法包括药物、行为矫正和认知行为干预，但很少有适应社区居民 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，旨在测试一种称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（具有同等治疗时间和治疗结构）进行比较。 ASMT 是一项为期 8 节的个人心理教育干预措施，基于自我监控和问题解决训练的原则。 ASMT 的单中心试点研究表明，从治疗前到治疗后，愤怒和愤怒表达的标准化测量有所改善；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。患有轻度、中度或重度 TBI 后至少 6 个月且存在愤怒问题的参与者，以及重要其他 (SO)（如果有），将按 2:1 随机分配至 ASMT 或 EPS。对治疗前和治疗后自我报告的愤怒测量的治疗反应将作为主要结果。共有 99 名参与者将从 3 个临床中心入组。次要结局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；和生活质量。将检查参与者的特征与治疗反应的关联。如果试验证明了进一步研究 ASMT 的价值，那么这种治疗模型最终可能会提供一种易于传播的方法，TBI 患者可以通过该方法学会重新获得个人对有问题的愤怒/烦躁的控制。

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.