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.

抽象的 高达 25% 的美国成年人有临床上显着的抑郁症状5,6 以及经历过这些症状的人 症状会增加全因死亡 7 和慢性病 8-23 的风险 活动 (PA) 有助于缓解抑郁症状27-31 并降低患 CVD 等慢性疾病的风险32-36 和 2 型糖尿病，37-41 尽管 PA 对患有抑郁症的人有好处。 抑郁症状，抑郁症状一致预测 PA 不依从性。42-45 因素，例如 痛苦耐受力下降 46-52 和积极性低下 53-60 使得遵守常规 PA 特别困难 因此，如何帮助有抑郁症状的成年人是一个需要解决的重要问题。 有抑郁症状的成年人克服了定期接受和承诺治疗的障碍。 (ACT)61,62 是一种基于正念的干预措施，可有效促进各种行为改变 健康人群和治疗抑郁症可以增强抑郁症患者的功能活动动机。 个人通过帮助他们澄清与行为目标一致的个人价值观，并培养现在- 时刻，不评判的意识（即正念）和接受内部经验以增加 ACT 的这些焦点可用于解决消极情感反应的不容忍问题。 PA 和 PA 动机低是有抑郁症状的成年人定期进行 PA 的障碍。 拟议项目的目标是进行一项可行性临床试验，将基于小组的 ACTivity 与 PA+教育针对 60 名低活动成年人（18-65 岁），他们在两个大学校期间抑郁症状加重 普罗维登斯 YMCA 分支机构的参与者将被随机分配接受治疗，并进行为期 6 个月的随访。 包括 8 周的治疗，并获得 6 个月的 YMCA 会员资格，以同等使用 PA 设施。 目标 1：开发并演示学士级别的培训和干预保真度程序 干预主义者指导 ACTivity 和 PA+Education 干预措施。 招募、随机化、保留和数据收集程序，以进行单独的随机化 团体治疗试验 (IRGT) 目标 3：展示可信度（即治疗的说服力和逻辑性）。 似乎）以及 ACTivity 和 PA+Education 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中心随机对照试验做准备的必要步骤 具体来说，如果证明有效，ACTivity 将提供一个社区—— 学士级别的工作人员可以在当地 YMCA 提供基于治疗的治疗，以提高 MVPA 抑郁的成年人，从而降低患慢性病的风险。