RCT of Behavioral Activation for Depression and Suicidality in Primary Care

描述（由申请人提供）： 抑郁症与相当大的发病率、死亡率和生活质量下降相关，包括社会功能、睡眠障碍、心血管事件和自杀想法/行为。抑郁症状是综合心理健康提供者最常见的转诊问题。虽然在初级保健中存在几种基于实践的抑郁症简短心理疗法，但提供这些心理疗法的最大障碍是治疗持续时间（例如，治疗的范围为6-8次30-50分钟），因为它不符合在初级保健中工作的精神健康提供者进行的典型治疗形式（即，1-4 15-30分钟的会议）。由于82%的VA初级保健诊所在初级保健中整合了心理健康提供者，因此确定基于证据的行为干预措施至关重要，这些干预措施可以应用于退伍军人报告这些环境中的全方位抑郁症状。最近的数据显示，在这些环境中工作的心理健康提供者报告使用BA元素作为与报告抑郁症状的退伍军人会面时最常见的临床干预措施之一。虽然传统的12-20节BA格式已被发现是一种有效的治疗退伍军人报告严重抑郁症，4节手动BA（BA-PC）的有效性抑郁症的严重程度和/或特定的抑郁症状尚未进行评估。总体目标是检查：1）与按需治疗（TAU）相比，4个疗程的手动BA-PC是否能有效减少抑郁症的特征，包括自我报告的抑郁症状和其他主观次要结局：睡眠障碍和生活质量结局; 2）检查患者对4个疗程BA-PC的满意度、参与度和接受度;（3）探讨BA-PC对自杀意念（SI）的影响。拟定研究是一项随机对照试验，采用意向治疗设计，有两种条件（4次BA-PC和TAU）。退伍军人将从VISN 2西部的三个VA初级保健机构（锡拉丘兹、罗切斯特和布法罗）招募。该研究的主要入选标准将是患者健康问卷-9（PHQ-9）上的抑郁症状报告，总分> 10，目前未从事抑郁症心理治疗的退伍军人将被要求参与。根据把握度分析，共有136名退伍军人将被随机化。这些退伍军人将根据（i）抑郁严重程度（基于其PHQ-9评分，“轻度至中度”vs.“重度”）和（ii）不存在/存在自杀意念进行分组，并随机分配接受4次BA-PC或TAU治疗。选择TAU对照条件是因为：1）在临床环境中测试改良治疗时，建议使用TAU条件; 2）为了最佳地告知VA培训工作，以管理初级保健中的抑郁症，证明4次BA-PC治疗相对于TAU治疗可以减少抑郁症的特征非常重要。所有退伍军人将每2周评估一次情绪变化，更全面的评估将在第6、12和24周完成。在进行描述性和简单统计以描述人群并确定条件、部位和患者亚组（例如，拒绝），多层次模型将主要用于检查目标。MLM提供了一种方法来检查这些关系，同时处理不完整的数据，而无需采用列表删除参与者。

DESCRIPTION (provided by applicant): Depression is associated with considerable morbidity, mortality and quality of life decrements including social functioning, sleep impairment, cardiovascular events, and suicidal thoughts/behaviors. Depressive symptoms are the most common referral problem to integrated mental health providers. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not meet the typical format of treatment conducted by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Because 82% of VA primary care clinics have integrated mental health providers in primary care, it is vital that evidence-based behavioral interventions be identified that can be applied with Veterans reporting the full-range of depressive symptoms within these settings. Recent data show that mental health providers working in these settings report using elements of BA as one of the most common clinical interventions used when meeting with Veterans reporting depressive symptoms. Although the traditional 12-20 session format of BA has been found to be an efficacious treatment for Veterans reporting severe depressive symptomatology, the effectiveness of a 4-session manualized BA (BA-PC) on depression severity and/or specific depressive symptoms has not been evaluated. The overarching objectives are to examine: 1) whether a 4-session manualized BA-PC compared to Treatment as Usual (TAU) is effective in reducing features of depression, including self-reported depressive symptoms and other subjective secondary outcomes: sleep impairment and quality of life outcomes; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) to explore the impact of BA-PC on suicidal ideation (SI). The proposed study is a randomized, controlled trial with two conditions (4-session BA-PC and TAU), using an intent to treat design. Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) with a total score > 10, such Veterans who are not currently engaged in psychological treatment for depression will be asked to participate. Based on a power analysis, a total of 136 Veterans will be targeted for randomization. These Veterans will be grouped on (i) depression severity ("mild to moderate" vs. "severe" based on their PHQ-9 scores) and (ii) absence/presence of suicidal ideation and randomly assigned to receive the 4-session BA-PC or TAU. A TAU control condition was chosen because 1) a TAU condition is recommended when testing a modified treatment within a clinical setting and 2) to optimally inform VA training efforts to manage depression in primary care it is important to demonstrate that a 4-session BA-PC can reduce features of depression relative to TAU. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks. After descriptive and simple statistics are conducted to describe the population and determine any differences among conditions, sites, and patient subgroups (e.g., declined), multi-level modeling will primarily be used to examine the aims. MLM provides a way to examine these relationships while handling incomplete data without resorting to listwise deletion of participants.