The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans with COPD, Emotion Distress, and Low Physical Activity

这项研究将开发和测试综合体力活动(PA)的可行性和有限效果 以及对患有COPD、情绪困扰的退伍军人的认知行为干预(BCBT)(临床 明显的抑郁和焦虑)，以及低PA水平。先前的研究表明，联合PA CBT 干预措施可为心力衰竭和糖尿病患者带来更好的身体和情绪结果。 从这篇文献中，我们将开发和测试一种综合的 PA CBT干预(STEP-CBT)为COPD患者量身定做和调整，并通过VA Video Connect提供 (VVC)。 STEP-CBT将是一种基于既定干预措施的综合干预措施：基于计步器的PA 干预和bCBT。为了开发STEP-CBT，我们将首先进行混合方法的访谈 20例患有慢性阻塞性肺疾病的退伍军人。混合方法数据将识别目标行为、情绪和认知 与情绪困扰和PA相关的内容，我们将把这些内容与 基于计步器的PA干预和bCBT。我们将根据患者的生活情况提供特定的语言 体验并反映他们用来描述自己经历的语言。我们将量身定做范例，首页 练习，以及基于我们收集的数据的心理教育。我们将适应通过VVC交付。STEP-CBT 然后将对(n=5)名退伍军人进行可接受性测试。将审查可接受性数据并将其提交给 审查和修改治疗方案的多学科专家小组将根据 这一过程。 接下来，将向退伍军人(n=32)提供STEP-CBT，与增强型普通护理(UC；n=16)相比 通过2：1随机抽样进行可行性和有限效果测试，从而匹配注册的社交 两周的磨合期。STEP-CBT将针对步数和患者报告的残疾的主要结果 (LLDFI残疾部分)和情绪困扰的次要结果(PHQ-9和BAI)。我们会 测量STEP-CBT组(n=32)和常规护理组(n=16)从基线到治疗后的组内变化 评估(第15周)。我们还将比较不同结果的组间差异。当可用时， 最不重要的差异将用于指导分析。这项研究将利用远程医疗方面的进展 干预措施。STEP-CBT将绕过众多障碍送到退伍军人家中 护理和增加接触更多患有慢性阻塞性肺病的退伍军人。来自CDA-2的试验数据将用于通知 未来功绩提交的设计和方法。 需要在四个领域开展高级教育和培训：1)肺康复和慢性阻塞性肺病；2) 行为改变科学；方法论和统计学；以及4)职业发展。这两种技术的结合 在这些领域的教学和经验培训将服务于PI成为一名独立的 波士顿退伍军人管理局的临床医生兼研究人员专注于开发创新的联合物理 活动/康复干预和心理健康干预，以优化老龄期间的身体功能 患有慢性病和身体残疾的退伍军人。在短期内，这一CDA-2将提供一个可行的， 以患者为中心的干预，可以纳入现有的护理系统和补充医院- 以肺康复为基础。

This study will develop and test the feasibility and limited-efficacy of a combined physical activity (PA) and cognitive-behavioral therapy intervention (bCBT) for Veterans with COPD, emotional distress (clinically significant depression and anxiety), and low PA level. Prior research has shown that combined PA+CBT interventions produce superior physical and emotional outcomes in heart failure and diabetes patients. Drawing from this body of literature, we will develop and test the feasibility and limited-efficacy of an integrated PA+CBT intervention (Step-CBT) tailored and adapted to COPD patients and delivered via VA Video Connect (VVC). Step-CBT will be an integrated intervention based on established interventions: pedometer-based PA intervention and bCBT. In order to develop Step-CBT, we will first conduct mixed-methods interviews with (n=20) Veterans with COPD. Mixed-methods data will identify target behaviors, emotions, and cognitions related to emotional distress and PA, and we will integrate this content with existing content included in pedometer-based PA intervention and bCBT. We will provide specific language based on patients' lived experience and mirror the language they use to describe their experience. We will tailor examples, home exercises, and psychoeducation based on the data we collect. We will adapt to delivery over VVC. Step-CBT will then be tested for acceptability with (n=5) Veterans. Acceptability data will be reviewed and submitted to the multidisciplinary expert panel for review and modifications of the treatment protocol will be made based on this process. Next, Step-CBT will be delivered to Veterans (n=32) compared to enhanced usual care (UC; n = 16) matched for social interaction enrolled through 2:1 randomization for feasibility and limited-efficacy testing with a two week run-in period. Step-CBT will target primary outcomes of step count and patient-reported disability (LLDFI Disability Component), and secondary outcomes of emotional distress (PHQ-9 and BAI). We will measure within-group change in Step-CBT (n=32) and usual care (n=16) groups from baseline to post- assessment (Week 15). We will also compare between-group differences across outcomes. When available, minimally important differences will be used to guide analyses. This study will leverage advances in telehealth interventions. Step-CBT will be deliverable to Veterans' home bypassing numerous barriers to hospital-based care and increasing access to more Veterans with COPD. Pilot data from this CDA-2 will be used inform the design and methodology of a future Merit submission. Advanced education and training is required in four areas: 1) Pulmonary Rehabilitation and COPD; 2) Science of behavior change; Methodology and Statistics; and 4) Career Development. The combination of didactic and experiential training in these areas will serve the PI's long-term goal of becoming an independent clinician-investigator at VA Boston focused on the development of innovative combined physical activity/rehabilitation interventions and mental health interventions, to optimize physical functioning in aging Veterans with chronic disease and physical disability. In the shorter-term, this CDA-2 will provide a feasible, patient-centered intervention that can be incorporated into existing systems of care and supplement hospital- based pulmonary rehabilitation.