Phone Cognitive Behavioral Therapy for Depression after Traumatic Brain Injury

描述(由申请人提供)：严重抑郁障碍(MDD)是创伤性脑损伤(TBI)患者中最常见的精神障碍，在受伤后的头几年最常见。颅脑损伤后的MDD与不良的行为、健康和功能结局相关。虽然神经因素在一定程度上促进了MDD在这一人群中的发展，但有证据表明，许多心理、社会和职业因素也起到了作用。在脑外伤患者中，MDD的有效治疗也存在多重障碍，包括：1)诊断不足和治疗不足；2)由于行动、交通和医疗福利的限制而得不到护理；3)脑外伤患者的神经认知障碍；4)同时存在的医疗和精神问题，包括药物滥用；5)缺乏社会支持和工作不稳定等压力源；以及6)脑外伤幸存者中关于抑郁症及其治疗的不准确信念。由于尚未在脑外伤患者身上进行MDD的心理治疗试验，基本的问题仍然是什么治疗方法在这一人群中是可行的、可接受的和有效的。因此，在进行随机对照试验之前，需要进行一项先导性研究，以确定受试者招募程序、对脑外伤患者的治疗适应以及创新的治疗提供模式是否有足够的前景开始大规模研究。借鉴了Simon等人开发的针对初级保健环境中抑郁症的成功的基于电话的认知行为疗法(CBT)。除了我们进行研究以改善脑外伤后预后的丰富经验外，我们还将进行一项为期12周的面对面或电话为基础的针对MDD的CBT手动干预(CBT-TBI)的双臂试点研究，该干预适用于复杂的轻、中或重度脑损伤患者。我们将评估这两种干预措施的可行性、患者满意度和治疗反应，以及数据收集的后勤和招募和保留的方法。我们将测试这一假设，即至少40%参加CBT-TBI的受试者，无论是面对面的还是基于电话的，都会对治疗有反应(报告在12周时汉密尔顿抑郁评定量表的分数与基线相比下降了50%)。与基线相比，次要结果将包括24周时的抑郁评分和与健康相关的生活质量(通过SF-36身心健康部分得分衡量)、脑震荡后症状(通过头部损伤症状检查表衡量)和功能状态(通过功能状态检查衡量)。我们还将研究行为(例如，愉快的事件)或认知(例如，抑郁思维)的变化是否是CBT疗效的中介。这项试点研究的结果将导致对CBT-TBI干预措施、招募程序、纳入/排除标准和样本量要求的改进。试点项目将有助于确定哪种治疗模式最具潜力，并将最终设计一项CBT-TBI的随机对照试验，以在具有代表性的脑损伤和MDD患者的大样本中测试其有效性。严重抑郁在创伤性脑损伤(TBI)患者中很常见。这项初步研究将确定面对面或通过电话进行认知行为疗法在治疗脑外伤患者抑郁(CBT-TBI)方面是否可行和有效。该项目将最终设计一项CBT-TBI试验，在具有代表性的脑损伤和抑郁症患者中进行大样本试验。

DESCRIPTION (provided by applicant): Major depressive disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute. There are also multiple barriers to effective treatment of MDD in persons with TBI, including: 1) under-diagnosis and under-treatment; 2) lack of access to care due to mobility, transportation and health care benefit limitations; 3) TBI neurocognitive impairments, 4) comorbid medical and psychiatric problems, including substance abuse; 5) stressors such as lack of social support and work instability; and 6) inaccurate beliefs about depression and its treatment among TBI survivors. Since no trials of psychotherapy for MDD have been conducted in persons with TBI, basic questions remain about what treatments are feasible, acceptable and effective in this population. Therefore, a pilot study is needed prior to conducting a randomized controlled trial in order to determine whether subject recruitment procedures, treatment adaptations for people with TBI, and an innovative treatment delivery model are promising enough to embark on a large scale study. Drawing from the successful telephone-based cognitive behavioral therapy (CBT) for depression in primary care settings developed by Simon et al. as well as our extensive experience conducting studies to improve outcomes after TBI, we will conduct a two arm pilot study of a 12-week in-person or telephone-based manualized CBT intervention for MDD adapted for persons with complicated mild, moderate or severe TBI (CBT-TBI). We will evaluate the feasibility, patient satisfaction, and therapeutic response to these two interventions as well as the logistics of data collection and methods for recruitment and retention. We will test the hypothesis that at least 40% of subjects enrolled in CBT-TBI, whether in-person or telephone-based, will respond to treatment (report a 50% decrease in Hamilton Depression Rating Scale scores at 12 weeks compared to baseline). Secondary outcomes will include depression scores at 24 weeks and health related quality of life (measured by the SF-36 physical and mental health component scores), postconcussive symptoms (measured by the Head Injury Symptom Checklist), and functional status (measured by the Functional Status Examination), compared to baseline. We will also examine whether changes in behaviors (e.g., pleasant events) or cognitions (e.g., depressive thinking) are mediators of CBT efficacy. Results from this pilot study will lead to refinements of the CBT-TBI intervention, recruitment procedures, inclusion/exclusion criteria, and sample size requirements. The pilot project will help to determine which treatment delivery model has the most potential and will culminate in the design of a randomized controlled trial of CBT-TBI to test its effectiveness in a large, representative sample of people with TBI and MDD. Significant depression is common among persons with traumatic brain injury (TBI). This preliminary study will determine if cognitive behavioral therapy administered in-person or over the telephone is feasible and effective in treating depression in people with TBI (CBT-TBI). This project will culminate in the design of a trial of CBT-TBI in a large, representative sample of people with TBI and depression.