Early phase clinical trial to test the feasibility of an ACT-based physical activity promotion program for adults with depressive symptoms

早期临床试验旨在测试基于 ACT 的体力活动促进计划针对患有抑郁症状的成年人的可行性

• 批准号: 10302469
• 负责人: David M Williams
• 金额: $ 36.97万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10302469
• 关键词: Accelerometer; Address; Adherence; Adoption; Adult; Aftercare; Age; Attention; Awareness; Behavioral; Benchmarking; Chronic; Chronic Disease; Client satisfaction; Clinical Practice Guideline; Clinical Trials; Data; Data Collection; Dementia; Depressed mood; Development; Distress; Economic Burden; Education; Educational Intervention; Enrollment; Fostering; Frequencies; Future; Goals; Health education; Individual; Intervention; Maintenance; Manuals; Mediator of activation protein; Mental Depression; Monitor; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Participant; Phase; Philanthropic Fund; Physical activity; Population; Procedures; Productivity; Protocols documentation; Psychologist; Questionnaires; Randomized; Research; Risk; Running; Site; Symptoms; Testing; Time; Training; Treatment Protocols; Work; base; behavior change; chronic back pain; clinically significant; community based treatment; depressive symptoms; disability; distress tolerance; early phase clinical trial; ethnic minority population; exercise intervention; experience; feasibility testing; feasibility trial; follow-up; mindfulness; motivational enhancement therapy; negative affect; primary outcome; programs; racial and ethnic; recruit; response; treatment group; treatment trial; trial comparing

ABSTRACT Up to 25% of U.S. adults have clinically significant depressive symptoms5,6 and people who experience these symptoms are at increased risk of all-cause mortality7 and chronic disease8-23 Engaging in regular physical activity (PA) can help alleviate depressive symptoms27-31 and reduce risk of chronic diseases, such as CVD32-36 and type 2 diabetes,37-41 that are associated with depression. Despite the benefits of PA for those with depressive symptoms, depressive symptoms consistently predict PA nonadherence.42-45 Factors such as decreased distress tolerance46-52 and low motivation53-60 make adherence to regular PA particularly difficult for adults with depressive symptoms. Thus, an important problem that needs to be addressed is how to help adults with depressive symptoms overcome barriers to regular PA. Acceptance and Commitment Therapy (ACT)61,62 is a mindfulness-informed intervention that is efficacious for fostering behavior change in various healthy populations and for treating depression. ACT enhances motivation for functional activities in depressed individuals by helping them to clarify personal values consistent with behavioral goals, and foster present- moment, nonjudgmental awareness (i.e., mindfulness) and acceptance of internal experiences to increase distress tolerance. These foci of ACT may be applied to address the intolerance of negative affective response to PA and low motivation for PA that serve as barriers to regular PA among adults with depressive symptoms. The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based ACTivity to PA+Education among 60 low-active adults (ages 18-65) with elevated depressive symptoms at two Greater Providence YMCA branches. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities. Aim 1: Develop and demonstrate training and intervention fidelity procedures for bachelor’s level interventionists to direct the ACTivity and PA+Education interventions. Aim 2: Demonstrate feasibility of recruitment, randomization, retention, and data collection procedures to conduct an individually randomized group treatment trial (IRGT). Aim 3: Demonstrate credibility (i.e., how convincing and logical a treatment seems) and acceptability of the ACTivity and PA+Education programs. Impact: The proposed research is a necessary step to prepare for a future multi-site RCT that has the potential to change clinical practice guidelines if shown to be effective. Specifically, if shown to be effective, ACTivity will provide a community- based treatment that can be delivered at local YMCAs by bachelor’s level staff to increase MVPA among depressed adults and thereby decrease their risk for chronic disease.

摘要 多达25%的美国成年人有临床上显著的抑郁症状5，6并且经历过这些症状的人 症状增加了各种原因致死的风险7和慢性病8-23经常进行体检 活动(PA)可以帮助缓解抑郁症状27-31，并降低患慢性病的风险，如CVD32-36 和2型糖尿病，37-41岁，与抑郁症有关。尽管PA对那些患有疾病的人有好处 抑郁症状，抑郁症状一致地预测PA不粘连。42-45因素 忧伤耐受性下降46-52和动力不足53-60使坚持常规PA特别困难 有抑郁症状的成年人。因此，需要解决的一个重要问题是如何帮助 有抑郁症状的成年人克服了常规PA的障碍。接纳与承诺疗法 (行动)61，62是一种正念知晓的干预，有效地促进各种不同的行为改变 健康人群和治疗抑郁症的药物。ACT增强抑郁症患者的功能性活动动机 通过帮助个人澄清与行为目标一致的个人价值观，并培养当下-- 时刻、不加评判的意识(即正念)和接受内在经验以增加 承受痛苦的能力。ACT的这些焦点可用于解决对负面情感反应的不耐受 对于有抑郁症状的成年人来说，对PA和对PA的低动机是阻碍其正常PA的因素。 拟议项目的目标是进行可行性临床试验，比较基于小组的活动和 60名年龄在18-65岁的低活动期抑郁症状加重的成年人的PA+教育 普罗维登斯基督教青年会分会。参与者将被随机分配到治疗条件下，随访6个月， 包括为期8周的治疗，并获得为期6个月的基督教青年会会员资格，以等同于使用PA设施。 目标1：开发和演示本科水平的培训和干预保真度程序 指导活动和PA+教育干预的干预者。目标2：论证 招募、随机化、保留和数据收集程序进行单独随机 团体治疗试验(IRGT)。目标3：证明可信度(即，如何令人信服和合乎逻辑的治疗 似乎)和活动和PA+教育计划的可接受性。影响：拟议的研究是一项 为未来可能改变临床实践的多部位随机对照试验做准备的必要步骤 指导方针，如果被证明是有效的。具体地说，如果证明是有效的，活动将提供一个社区- 可由学士级别的工作人员在当地基督教青年会提供的基础治疗，以增加MVPA 抑郁的成年人，从而降低他们患慢性病的风险。