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

针对患有慢性阻塞性肺病、情绪困扰和体力活动不足的退伍军人制定综合体力活动和心理健康干预措施

• 批准号: 10304334
• 负责人: Patricia Bamonti
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2026-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10304334
• 关键词: Aging; Ambulatory Care; Anxiety; Area; Behavior; Boston; Bypass; COVID-19 intervention; COVID-19 pandemic; Caring; Cause of Death; Cessation of life; Chronic Disease; Chronic Obstructive Pulmonary Disease; Cognition; Cognitive Therapy; Complex; Data; Development; Diabetes Mellitus; Disease; Disease Outcome; Distress; Dyspnea; Emotional; Emotions; Enrollment; Exercise; Fatigue; Future; Goals; Health Services Accessibility; Heart failure; Home; Home environment; Hospitalization; Hospitals; Intervention; Interview; Label; Language; Life; Literature; Longitudinal Studies; Maintenance; Measures; Mental Depression; Mental Health; Methodology; Methods; Modification; Monitor; Morbidity - disease rate; Outcome; Patient Self-Report; Patients; Pattern; Periodicity; Persons; Physical Function; Physical activity; Problem Solving; Process; Protocols documentation; Quality of life; Randomized; Rehabilitation therapy; Reporting; Research; Research Personnel; Risk; Running; SARS-CoV-2 infection; Science; Self Management; Services; Social Interaction; Strategic Planning; Technology; Testing; Therapeutic Intervention; Thinking; Time; Training; Training and Education; Treatment Protocols; Veterans; anxiety symptoms; base; behavior change; burden of illness; care systems; career development; clinically significant; comorbid depression; comorbidity; depressive symptoms; design; disability; efficacy testing; emotional distress; exercise intervention; experience; feasibility testing; improved; innovation; modifiable behavior; mortality risk; multidisciplinary; participant retention; patient oriented; pedometer; physically handicapped; primary outcome; psychoeducation; psychologic; pulmonary rehabilitation; recruit; rehabilitation research; research and development; response; screening; secondary outcome; severe COVID-19; standard care; statistics; symptomatology; telehealth; treatment adherence; treatment as usual; treatment guidelines; treatment response

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.

这项研究将开发和测试的可行性和有限的有效性，结合身体活动（PA） 和认知行为治疗干预（bCBT）的退伍军人与COPD，情绪困扰（临床 显著抑郁和焦虑）和低PA水平。先前的研究表明，PA+CBT 干预措施在心力衰竭和糖尿病患者中产生上级身体和情绪结果。 从这一机构的文献，我们将开发和测试的可行性和有限的功效，综合 PA+CBT干预（Step-CBT）针对COPD患者量身定制，并通过VA视频连接提供 （VVC）。 Step-CBT将是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访谈， （n=20）COPD退伍军人。混合方法数据将识别目标行为、情感和认知 有关情绪困扰和PA，我们将整合此内容与现有的内容，包括在 基于计步器的PA干预和bCBT。我们将根据患者的生活提供具体的语言 体验和反映他们用来描述他们体验的语言。我们将量身定制的例子，家 练习，并根据我们收集的数据进行心理教育。我们将适应通过VVC进行交付。分步CBT 然后将与（n=5）退伍军人一起测试可接受性。将对可接受性数据进行审查并提交至 多学科专家小组审查和修改治疗方案将根据 这个过程 接下来，与增强型常规护理（UC; n = 16）相比，将向退伍军人（n=32）提供Step-CBT 通过2：1随机化入组，进行可行性和有限疗效试验， 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局 （LLDFI残疾成分）和情绪困扰（PHQ-9和BAI）的次要结局。我们将 测量Step-CBT组（n=32）和常规治疗组（n=16）从基线至治疗后的组内变化 评估（第15周）。我们还将比较结果的组间差异。如果可以的话， 最小的重要差异将用于指导分析。这项研究将利用远程医疗的进步 干预措施。Step-CBT将被送到退伍军人的家中，绕过医院的众多障碍。 护理和增加获得更多的退伍军人与慢性阻塞性肺病。来自CDA-2的试点数据将用于通知 未来Merit提交的设计和方法。 需要在四个方面进行高级教育和培训：1）肺康复和COPD; 2） 行为改变科学;方法学和统计学;以及4）职业发展。的组合 这些领域的教学和经验培训将服务于PI成为独立的长期目标。 VA波士顿的临床研究员专注于开发创新的组合物理 活动/康复干预措施和心理健康干预措施，以优化衰老过程中的身体功能 患有慢性病和身体残疾的退伍军人。从短期来看，CDA-2将提供一个可行的、 以患者为中心的干预措施，可以纳入现有的护理系统，并补充医院- 肺康复的基础。