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

摘要 高达25%的美国成年人患有临床上显著的抑郁症5，6， 症状是在增加风险的所有原因死亡7和慢性疾病8 -23从事定期体检 活动（PA）可以帮助缓解抑郁症27 -31，并降低慢性疾病的风险，如心血管疾病32 -36 和2型糖尿病，37-41与抑郁症有关。尽管PA对那些 抑郁症状，抑郁症状一致预测PA不依从性。42 -45因素，如 痛苦耐受力下降46 -52和低动机53 -60使得坚持定期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。接受和承诺疗法 （ACT）61，62是一种正念知情干预，对促进各种行为改变有效。 健康人群和治疗抑郁症。ACT增强抑郁症患者功能活动的动机 个人，帮助他们澄清与行为目标相一致的个人价值观，并促进目前的- 时刻，非判断性意识（即，正念）和接受内部经验，以增加 痛苦承受力ACT的这些焦点可用于解决负性情感反应的不耐受 PA和PA的低动机，作为障碍，以定期PA在成年人与抑郁症状。 拟议项目的目标是进行一项可行性临床试验，比较基于组的ACTIVITY与 PA+教育在60个低活动的成年人（18-65岁）中，在两个更大的年龄段有抑郁症状升高 普罗维登斯基督教青年会的分支机构。受试者将被随机分配至治疗条件，随访6个月， 包括8周的治疗，并获得6个月的基督教青年会会员资格，以平等地获得PA设施。 目标1：开发和展示学士水平的培训和干预保真度程序 干预者指导活动和PA+教育干预措施。目标2：证明 招募、随机化、保留和数据收集程序，以进行个体随机化 分组治疗试验（IRGT）。目标3：展示可信度（即，一种治疗方法是多么令人信服和合乎逻辑 似乎）和活动和PA+教育计划的可接受性。影响：拟议的研究是一个 准备未来可能改变临床实践的多中心RCT的必要步骤 指导方针如果被证明是有效的。具体来说，如果被证明是有效的，ACTIVITY将提供一个社区- 基于治疗，可以在当地基督教青年会提供学士学位的工作人员，以增加MVPA之间 抑郁的成年人，从而降低他们患慢性病的风险。

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.