Phone Cognitive Behavioral Therapy for Depression after Traumatic Brain Injury

电话认知行为疗法治疗脑外伤后抑郁症

• 批准号: 7254284
• 负责人: Jesse R Fann
• 金额: $ 23.4万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7254284
• 关键词: Address; Adherence; Adverse effects; Antidepressive Agents; Behavior; Behavioral; Belief; Characteristics; Client satisfaction; Cognition; Cognitive Therapy; Control Groups; Craniocerebral Trauma; Data; Data Collection; Development; Diagnosis; Digit structure; Doctor of Philosophy; Drops; Effectiveness; Enrollment; Event; Exclusion Criteria; Expert Opinion; Future; Goals; Grant; Hamilton Rating Scale for Depression; Health; Health Services Accessibility; Healthcare; Impaired cognition; Impairment; Information Systems; Injury; Intervention; Lead; Logistics; Major Depressive Disorder; Manuals; Measures; Mediator of activation protein; Medical; Mental Depression; Mental Health; Mental disorders; Methods; Modeling; Modification; Multiple Sclerosis; Neurocognitive; Neurologic; Outcome; Outcome Measure; Participant; Patients; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Pilot Projects; Population; Primary Health Care; Procedures; Process; Protocols documentation; Psychosocial Factor; Psychotherapy; Publishing; Randomized; Randomized Controlled Trials; Rate; Recruitment Activity; Reporting; Research; Research Design; Rewards; Risk; SF-36; Sample Size; Sampling; Score; Sertraline; Social support; Solid; Statistically Significant; Substance abuse problem; Surveys; Survivors; Symptoms; TBI Patients; Telephone; Testing; Therapeutic; Thinking; Transportation; Traumatic Brain Injury; Treatment Efficacy; Treatment Protocols; Upper arm; Verbal Learning; Waiting Lists; Week; Work; base; behavioral health; cohort; depressive symptoms; design; double-blind placebo controlled trial; experience; functional outcomes; functional status; health related quality of life; improved; innovation; interest; neurobehavioral; pilot trial; psychologic; response; response to injury; social; stressor; treatment duration; treatment trial

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.

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疾病，在受伤后的最初几年中最常见。TBI后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有助于这一人群中MDD的发展，但有证据表明，许多心理，社会和职业因素也有贡献。在TBI患者中有效治疗MDD也存在多种障碍，包括：1）诊断不足和治疗不足; 2）由于流动性、交通和医疗保健福利限制而缺乏获得护理的机会; 3）TBI神经认知障碍; 4）合并的医疗和精神问题，包括药物滥用; 5）压力源，如缺乏社会支持和工作不稳定;（6）TBI幸存者对抑郁症及其治疗的不准确信念。由于没有在TBI患者中进行MDD的心理治疗试验，因此仍然存在一些基本问题，即什么样的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提供模式是否足以进行大规模研究。借鉴Simon等人在初级保健环境中成功开发的基于电话的认知行为疗法（CBT）治疗抑郁症，以及我们开展研究以改善TBI后结局的丰富经验，我们将进行一项为期12周的面对面或基于电话的手动CBT干预的两组试点研究，适用于复杂的轻度、中度或重度TBI患者（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，以及数据收集的物流和招募和保留方法。我们将检验以下假设：至少40%的CBT-TBI受试者（无论是面对面还是电话）将对治疗产生应答（报告第12周时汉密尔顿抑郁评定量表评分较基线降低50%）。次要结局将包括与基线相比，24周时的抑郁评分和健康相关生活质量（通过SF-36身体和精神健康成分评分测量）、脑震荡后症状（通过头部损伤症状检查表测量）和功能状态（通过功能状态检查测量）。我们还将研究行为的变化（例如，愉快的事件）或认知（例如，抑郁思维）是CBT疗效的中介。这项试点研究的结果将导致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CBT-TBI的随机对照试验，以测试其在TBI和MDD患者的大型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是否认知行为疗法管理的人或通过电话是可行的和有效的治疗抑郁症的人与TBI（CBT-TBI）。该项目将最终在一个大的，有代表性的TBI和抑郁症患者样本中设计CBT-TBI试验。