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: 8514951
• 负责人: Tessa Hart
• 金额: $ 46.43万
• 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/8514951
• 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）：在损伤严重程度范围内创伤性脑损伤（TBI）后，有问题的愤怒和易怒是常见的，并且持续存在。愤怒症状对情感健康，社区生活以及家庭和社会关系产生负面影响。 TBI之后的有问题的愤怒有许多原因，包括受伤的有机和非有机或次要影响。执行功能的特征缺陷，例如自我监控和解决问题的缺陷受损，也起着作用。可用的治疗包括药物，行为修改和认知行为干预措施，但很少有人适应具有TBI的社区住宅的需求，并且很少进行治疗试验。本研究是一项II期临床试验，旨在测试一种新型治疗方法，称为“愤怒自我管理训练（ASMT）”，与提供教育和心理支持（EPS）具有同等治疗师时间和治疗结构的对照治疗相比。 ASMT是基于自我监控和解决问题的培训原则的8条，个人，心理教育干预措施。一项对ASMT的单中心试点研究表明，从治疗前到治疗，对愤怒和愤怒表达的标准化度量的改善；本试验的目的是将其与更大，更多样化的样本中的EPS进行比较。有问题的愤怒的参与者至少在复杂的轻度，中度或重度TBI之后至少6个月，并且其他重要的（SO）（如果有）将被随机2：1与ASMT或EPS。对自我报告的愤怒措施的治疗反应将作为主要结果。总共99名参与者将从3个临床部位招收。次要结果包括轨迹和治疗反应的持久性；改变所说的参与者的愤怒；情感和行为状态；和生活质量。将检查参与者的特征与治疗反应的关联。如果该试验证明了对ASM的进一步研究的价值，则该治疗模型最终可能会提供一种容易分辨的方法，通过这种方法，TBI的人可以学会重新获得对有问题的愤怒/烦恼的个人控制。