Transdiagnostic Treatment for Anxiety and Bipolar I Disorder

描述（申请人提供）：为该奖学金提出的研究的具体目标是调查专为针对情绪和焦虑障碍的共同核心过程而开发的transdiagnosis，认知行为疗法的可行性，可接受性和初步疗效[情绪障碍transdiagnosis治疗的统一协议（UP）]1，用于治疗双相I型障碍（BD-I）和共病焦虑症患者。开展本项目将为研究者提供以下方面的宝贵培训： 临床试验的成功实施。本研究将比较常规治疗与药物治疗（TAU）加18次1小时UP治疗与单独TAU治疗。这两种治疗条件下的患者将在12个月内进行随访，并每月进行评估，以跟踪情绪，焦虑和情绪相关症状的变化;功能障碍;和复发率。将通过每月患者自我报告的治疗满意度评级，并通过跟踪随机化入组研究的接受率、完成的疗程数量和脱落率，同时收集治疗可接受性数据。这项研究将审查：1）联合认知行为治疗（UP）对BD-Ⅰ和共病焦虑障碍是否是一种可接受和可行的治疗方法; 2）与单独的药物治疗相比，用UP治疗BD-I和共病焦虑障碍作为药物治疗照常治疗（TAU）的辅助治疗是否导致更大的症状减轻和减少的功能损害，3）在6个月的随访中，与TAU相比，用UP治疗BD-I和共病焦虑障碍是否改善了复发率;以及4）症状、复发率和功能障碍的减轻是否由情绪调节技能的变化介导。这项研究的更广泛的目的是解决双相情感障碍的治疗需要改进。双相情感障碍是一种慢性和使人衰弱的疾病，与显著的个人和公共卫生成本相关。BD-I的12个月成人患病率为2.6%，其中83%被归类为“重度”，48%使用医疗保健服务。2超过86%的BD-I患者终身诊断为焦虑共病。3目前和终身共病焦虑的存在已被确定为BD-I严重程度较高的独立标志物，并与更高的慢性化相关，治疗反应降低，功能障碍加重。4，5因此，在BD-I背景下治疗焦虑对于改善病程和结局至关重要。开发BD-I与共病焦虑的治疗方法被认为是双相情感障碍领域最大的未满足需求之一。拟议的项目旨在解决这一公共卫生需求，同时推进和发展申请人的培训目标，以熟练进行临床试验。 公共卫生相关性：双相I型障碍（BD-I）是一种慢性和使人衰弱的疾病，与显著的个人和公共卫生成本相关，12个月成人患病率为2.6%，83%被归类为“重度”，48%使用医疗保健服务。2超过86%的BD-I患者终身诊断为共病焦虑，3与更高的慢性病，降低的治疗反应，因此，开发针对BD-I背景下共病焦虑的治疗方法对于改善病程和结局至关重要，并解决了双相情感障碍领域最大的未满足需求之一。

DESCRIPTION (provided by applicant): The specific goal of the research study proposed for this fellowship is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)]1, for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. Conducting this project will provide the investigator with invaluable training in the successful implementation of clinical trials. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion- related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder. Bipolar disorder is a chronic and debilitating disorder, associated with significant personal and public health costs. Twelve-month adult prevalence rates of BD-I are 2.6%, with 83% classified as "severe," and 48% utilizing health care services.2 Greater than 86% of BD-I patients have a lifetime diagnosis of comorbid anxiety.3 The presence of both current and lifetime comorbid anxiety has been identified as an independent marker of greater BD-I severity, and is associated with greater chronicity, reduced treatment response, and greater functional impairment.4,5 Therefore, treating anxiety in the context of BD-I is crucial for improving illness course and outcomes. Developing treatments for BD-I with comorbid anxiety is recognized as one of the greatest unmet needs in the field of bipolar disorder. The proposed project is intended to address this public health need, while simultaneously advancing and developing the applicant's training goals to become adept at conducting clinical trials. PUBLIC HEALTH RELEVANCE: Bipolar I disorder (BD-I) is a chronic and debilitating disorder, associated with significant personal and public health costs, with 12-month adult prevalence rates at 2.6%, 83% classified as "severe," and 48% utilizing health care services.2 Greater than 86% of BD-I patients have a lifetime diagnosis of comorbid anxiety,3 associated with greater chronicity, reduced treatment response, and greater functional impairment.4, 5 Therefore, developing treatments that target comorbid anxiety in the context of BD-I is crucial for improving illness course and outcomes, and addresses one of the greatest unmet needs in the field of bipolar disorder.