一项涉及运动和行为激活以治疗2型糖尿病合并重度抑郁症的试点随机临床试验的设计与方法
Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder.
作者信息
Schneider Kristin L, Pagoto Sherry L, Handschin Barbara, Panza Emily, Bakke Susan, Liu Qin, Blendea Mihaela, Ockene Ira S, Ma Yunsheng
机构信息
Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA USA.
出版信息
Ment Health Phys Act. 2011 Jun 1;4(1):13-21. doi: 10.1016/j.mhpa.2011.04.001.
BACKGROUND
The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. METHODS/DESIGN: Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. DISCUSSION: A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. TRIAL REGISTRATION: NCT01024790.
背景
2型糖尿病（T2DM）与抑郁症的合并症与血糖控制不佳有关。运动已被证明可以改善情绪和血糖控制，但与普通人群相比，合并T2DM和抑郁症的个体久坐不动的比例过高，且报告称运动困难更大。行为激活是一种循证抑郁症心理治疗方法，旨在帮助抑郁症患者逐渐改变行为，可能有助于提高久坐人群的运动依从性。这项初步随机临床试验将测试在合并T2DM和抑郁症的女性中采用行为激活策略强化的团体运动计划的可行性。
方法/设计：久坐不动、T2DM控制不佳且患有抑郁症的女性（N = 60）将被随机分配到两种情况之一：运动组或常规护理组。随机分配到运动组的参与者除接受常规护理外，还将在24周内参加38节行为激活强化团体运动课程。随机分配到常规护理组的参与者将获得抑郁症治疗转诊，并收到关于通过饮食和体育活动进行糖尿病管理的印刷信息。评估将在基线以及随机分组后的3个月、6个月和9个月进行。这项初步研究的目标是证明可行性和干预可接受性，估计实施干预所需的资源和成本，并估计连续结果（如抑郁症状和糖化血红蛋白）的标准差，为全面的随机临床试验做准备。
讨论
一种将运动和行为激活策略相结合的新型干预措施可能会改善合并2型糖尿病和抑郁症女性的血糖控制和情绪。
试验注册
NCT01024790
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