RCT of Behavioral Activation for Depression and Suicidality in Primary Care

初级保健中抑郁症和自杀行为激活的随机对照试验

• 批准号: 9768223
• 负责人: Jennifer S Funderburk
• 金额: --
• 依托单位: SYRACUSE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2020-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768223
• 关键词: Adherence; Barium; Behavior; Behavior Therapy; Behavioral; Brief Psychotherapy; Buffaloes; Cardiovascular system; Caring; Client satisfaction; Clinic; Clinical; Data; Depression and Suicide; Effectiveness; Event; Feeling suicidal; Goals; Health; Health Personnel; Intervention; Measures; Mental Depression; Mental Health; Modeling; Moods; Morbidity - disease rate; Outcome; PC3 cell line; Participant; Patient Self-Report; Patients; Population; Prevalence; Primary Health Care; Provider; Psychological reinforcement; Psychotherapy; Publishing; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Resort; Rewards; Severities; Site; Sleep; Sleep disturbances; Social Functioning; Techniques; Testing; Training; Veterans; base; depressive symptoms; design; effective therapy; effectiveness evaluation; evidence base; follow-up; improved; inclusion criteria; meetings; mortality; multilevel analysis; patient subsets; pleasure; power analysis; primary care setting; primary outcome; psychologic; recruit; reducing suicide; response; satisfaction; secondary outcome; service utilization; statistics; suicidal risk; symptomatology; treatment as usual; treatment duration

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.

描述（由申请人提供）： 抑郁症与相当大的发病率，死亡率和生活质量降低有关，包括社会功能，睡眠障碍，心血管事件和自杀思想/行为。抑郁症状是综合心理健康提供者最常见的转诊问题。尽管有几种基于经验的初级保健抑郁症的简短心理治疗，但提供这些心理治疗的最重要障碍是治疗持续时间（例如，治疗范围为6-8次30-50分钟的治疗范围），因为它不符合典型的治疗形式，由精神卫生提供者在初级保健中工作的精神卫生提供者进行的治疗形式（i.e.e.e.，1-4 15-30分钟）。由于82％的VA初级保健诊所已将精神卫生提供者纳入初级保健，因此必须确定可以与退伍军人一起使用基于证据的行为干预措施，以在这些情况下报告抑郁症状的全范围。最近的数据表明，在这些环境报告中工作的心理健康提供者使用BA的元素是与退伍军人举报抑郁症状的最常见临床干预措施之一。尽管已经发现传统的12-20个会议格式是对报道严重抑郁症状学的退伍军人的有效治疗方法，但尚未评估4间课程手动BA（BA-PC）对抑郁严重程度和/或特定抑郁症状的有效性。总体目标是检查：1）与往常一样（TAU）相比，4条经验的BA-PC是否有效地减少抑郁症的特征，包括自我报告的抑郁症状和其他主观的次要结果：睡眠障碍和生活质量的生活质量； 2）检查患者对4会议BA-PC的患者满意度，参与度和接受性； 3）探索BA-PC对自杀意念（SI）的影响。拟议的研究是一项随机，对照试验，具有两种条件（4会议BA-PC和TAU），使用了治疗设计的意图。退伍军人将从VISN 2（锡拉丘兹，罗切斯特和布法罗）西部的三个VA初级保健环境中招募。该研究的主要纳入标准将是关于患者健康问卷-9（PHQ-9）的抑郁症状的报告，总分> 10，目前尚未从事抑郁症心理治疗的退伍军人将被要求参加。基于功率分析，将总共136名退伍军人作为随机分组。这些退伍军人将分组（i）抑郁严重程度（根据他们的PHQ-9分数，“轻度到中度”与“严重”）和（ii）缺乏自杀念头，并随机分配以接收4会议的BA-PC或TAU。选择了TAU控制条件，因为1）建议在临床环境中测试改良治疗时，建议采用TAU状况，并且2）为了最佳地告知VA培训工作以管理基层医疗中的抑郁症，重要的是要证明，相对于TAU，4节奏BA-PC可以减少抑郁症的特征。所有退伍军人将每2周评估一次，以改变情绪的变化，并将在6、12和24周完成更全面的评估。进行描述性和简单统计数据以描述种群并确定条件，地点和患者亚组之间的任何差异（例如，拒绝），多级建模将主要用于检查目的。 MLM提供了一种在处理不完整数据的同时检查这些关系的方法，而无需诉诸参与者的列表删除。