Phone Cognitive Behavioral Therapy for Depression after Traumatic Brain Injury

描述（由申请人提供）：重度抑郁症（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。TBI后的重度抑郁症与不良的行为、健康和功能结果相关。虽然神经因素在一定程度上影响了这一人群的重度抑郁症的发展，但有证据表明，许多心理、社会和职业因素也有影响。对脑外伤患者的重度抑郁症进行有效治疗也存在多重障碍，包括：1)诊断和治疗不足；2)由于流动性、交通和保健福利的限制，缺乏获得保健的机会；3) TBI神经认知障碍；4)共病的医学和精神问题，包括药物滥用；5)缺乏社会支持和工作不稳定等压力源；6)创伤性脑损伤幸存者对抑郁症及其治疗的错误认识。由于没有在脑外伤患者身上进行过重度抑郁症的心理治疗试验，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，需要进行一项试点研究，以确定受试者招募程序、TBI患者的治疗适应性以及创新的治疗交付模式是否有足够的希望开展大规模研究。借鉴Simon等人开发的基于电话的抑郁症认知行为疗法（CBT）在初级保健机构中取得的成功，以及我们开展研究以改善TBI后结果的丰富经验，我们将开展一项两组试点研究，针对重度抑郁症患者进行为期12周的面对面或基于电话的手动CBT干预，适用于复杂的轻度、中度或重度TBI （CBT-TBI）。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方法。我们将检验这样一个假设，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，对治疗有反应（报告12周时汉密尔顿抑郁评定量表得分与基线相比下降50%）。次要结局将包括与基线相比的24周抑郁评分和健康相关的生活质量（由SF-36身心健康成分评分测量）、脑震荡后症状（由头部损伤症状清单测量）和功能状态（由功能状态检查测量）。我们还将研究行为（如愉快事件）或认知（如抑郁思维）的变化是否为CBT效果的中介。该试点研究的结果将导致对CBT-TBI干预、招募程序、纳入/排除标准和样本量要求的改进。该试点项目将有助于确定哪种治疗模式最有潜力，并最终设计一项CBT-TBI的随机对照试验，以测试其在TBI和重度抑郁症患者的大量代表性样本中的有效性。严重的抑郁症在创伤性脑损伤（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的认知行为疗法（CBT-TBI）在治疗脑外伤患者抑郁症方面是否可行和有效。该项目最终将设计一项CBT-TBI试验，该试验将在大量具有代表性的TBI和抑郁症患者样本中进行。

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.