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

急性创伤性脑损伤后的愤怒自我管理：临床试验

• 批准号: 8707242
• 负责人: Tessa Hart
• 金额: $ 48.06万
• 依托单位: ALBERT EINSTEIN HEALTHCARE NETWORK
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8707242
• 关键词: Acute; Aftercare; Aggressive behavior; Anger; Attention; Behavior Therapy; Behavioral; Caring; Case Mixes; Characteristics; Clinic; Clinical Trials; Clinical Trials Design; Cognitive; Cognitive Therapy; Communities; Education; Educational Intervention; Emotional; Enrollment; Equipment and supply inventories; Exhibits; Family; Friends; Friendships; Gender; Goals; Health; Individual; Injury; Learning; Life; Masks; Measures; Memory; Methods; Modeling; Monitor; Outcome; Outcome Assessment; Participant; Patient Self-Report; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Pilot Projects; Play; Post-Traumatic Stress Disorders; Problem Solving; Quality of life; Questionnaires; Randomized; Relative (related person); Reporting; Role; Sampling; Self Management; Self Perception; Severities; Structure; Support Groups; Symptoms; Teaching Method; Testing; Therapeutic; Time; Training; Training and Education; Traumatic Brain Injury; Work; base; clinical research site; community living; coping; design; emotional distress; executive function; novel; primary outcome; psychologic; racial and ethnic; response; satisfaction; secondary outcome; social; standardize measure; trait; treatment effect; treatment response; treatment site; treatment trial

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.

描述（由申请人提供）：在创伤性脑损伤（TBI）后，问题性愤怒和易怒是常见的和持续的，跨越了损伤严重程度的范围。愤怒症状对情绪健康、社区生活、家庭和社会关系都有负面影响。创伤性脑损伤后的问题性愤怒有很多原因，包括器质性和非器质性或损伤的继发性影响。执行功能的特征性缺陷，如自我监控受损和解决问题的缺陷，也起作用。现有的治疗方法包括药物治疗、行为矫正和认知行为干预，但很少有适合社区居住的TBI患者的需要，也很少进行治疗试验。目前的研究是一项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，后者具有相同的治疗师时间和治疗结构。ASMT是一种基于自我监控和问题解决训练原则的8期个体心理教育干预。一项针对ASMT的单中心试点研究显示，治疗前后，愤怒和愤怒表达的标准化测量指标有所改善；本试验的目的是将其与EPS在更大、更多样化的样本中进行比较。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，并且有一个重要的另一半（SO），如果有的话，将按2:1随机分配到ASMT或EPS。治疗前和治疗后对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个临床站点入组。次要结局包括治疗反应的轨迹和持续时间；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。参与者的特征将被检查其与治疗反应的关系。如果试验证明了进一步研究ASMT的价值，这种治疗模式可能最终提供一种易于推广的方法，通过这种方法，TBI患者可以学会重新控制有问题的愤怒/易怒。