The Emotion Builder: An Intervention for Emotional Deficits after Brain Injury

描述（由申请人提供）：创伤性脑损伤（TBI）患者经常受到社会情绪缺陷的困扰，包括难以识别自己的情绪（述情障碍），难以识别他人的情绪（受损的情感识别），以及同理心丧失。这些非常普遍的缺陷，占中度至重度TBI人群的39-70%，具有重要意义，因为它们与情绪控制不良、行为不当、负面社会结果、社区融入和生活质量降低有关。康复服务的一个主要限制是，对于创伤性脑损伤后的述情障碍、情感识别和共情缺陷，没有标准的、基于证据的治疗方法。因此，治疗师和康复机构没有足够的设备来治疗创伤性脑损伤患者的这些损伤。因此，迫切需要一种能够有效解决这些社会情感问题的干预措施。为了满足这一需求，EmotEd， LLC将与印第安纳大学和印第安纳康复医院的研究伙伴合作，开发和销售一种高质量的、基于证据的产品，用于治疗述情障碍、影响识别和移情缺陷。这个名为“情感构建者tm”的产品将是一个严肃的虚拟环境（VE）视频游戏，临床医生将使用它来教TBI患者在自然的社交场景中克服这些缺陷。它将包含三个治疗模块：述情障碍、情感识别和同理心。对于拟议的第一阶段STTR项目，主要目标将是开发和初步评估Emotion BuilderTM的述情障碍模块。目的1是制定详细的治疗方案，以减少创伤性脑损伤后述情障碍。目标二是开发一个测试版本的VE严肃视频游戏，情感建设者tm，以支持述情障碍，并在该协议中提供帮助。目的3是证明情绪构建器tm治疗创伤性脑损伤患者述情障碍的可行性。可行性将通过一项使用前/后测试设计的试点研究来证明，以确定产品需求、可接受性和治疗脑外伤后述情障碍的效果大小（n=15）。如果成功，第二阶段的目标是将情感识别和共情模块添加到情绪构建器tm中，并进行大规模的随机对照试验，以确定效果、行为的泛化和技能保留

DESCRIPTION (provided by applicant): People with traumatic brain injury (TBI) are often plagued with socio-emotional deficits that include difficulty identifying emotions in oneself (alexithymia), difficulty recognizing other peoples' emotions (impaired affect recognition), and empathy loss. These highly prevalent deficits, ranging between 39-70% of the moderate to severe TBI population, are significant because they are associated with poor emotional control, inappropriate behavior, negative social outcomes, and reduced community integration and quality of life. A major limitation of rehabilitation services is that there are no standard, evidece-based treatments for alexithymia, affect recognition, and empathy deficits after TBI. As a result, therapists and rehabilitation facilities are not equipped to adequately treat these impairments in patients with TBI. Consequently, there is a robust need for an intervention that can effectively address these socio-emotional problems. In order to meet this need, EmotEd, LLC will work with research partners at Indiana University and the Rehabilitation Hospital of Indiana to develop and market a high quality, evidence-based product to treat alexithymia, affect recognition, and empathy deficits. This product, entitled the Emotion BuilderTM, will be a serious virtual environment (VE) video game that will be used by clinicians to teach patients with TBI to overcome these deficits in naturalistic social scenarios. It will contain three treatment modules: alexithymia, affect recognition, and empathy. For the proposed Phase I STTR project, the main objective will be the development and preliminary evaluation of the alexithymia module of the Emotion BuilderTM. Aim 1 is to develop a detailed treatment protocol to reduce alexithymia after TBI. Aim 2 is to develop a beta version of a VE serious video game, the Emotion BuilderTM, to support the alexithymia t r e a t m e n t protocol. Aim 3 is to demonstrate the feasibility of the Emotion BuilderTM to treat alexithymia in people with TBI. Feasibility will be demonstrated with a pilot study using a pre/ post-test design to determine product demand, acceptability, and treatment effect size on alexithymia after TBI (n=15). If successful, Phase II will aim to add affect recognition and empathy modules to the Emotion BuilderTM, and to conduct a large scale randomized control trial to determine efficacy, generalization of behavior, and skill retention for the comprehensive program. Short-term, the contribution of this project will be significant because it is the first step towards meeting the need for treatments that can effectively address emotional deficits after TBI. Long-term contributions are expected to minimize problems with alexithymia, affect recognition, empathy loss, and related socio-emotional problems for many people with TBI; enrich interpersonal relationships; and enhance community participation and quality of life after TBI. The video game format permits delivery either in the clinic or via home-based tele- rehabilitation, maximizing the number of patients who could benefit. There are no comparable treatments to the Emotion BuilderTM, poising this markedly innovative product to be in high demand.