Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder
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Authors
Schneider, Kristin L.Pagoto, Sherry L.
Handschin, Barbara
Panza, Emily
Bakke, Susan
Liu, Qin
Blendea, Mihaela
Ockene, Ira S.
Ma, Yunsheng
UMass Chan Affiliations
Department of Medicine, Division of Cardiovascular MedicineDepartment of Medicine, Division of Preventive and Behavioral Medicine
Document Type
Journal ArticlePublication Date
2011-06-01Keywords
Diabetes Mellitus, Type 2Depressive Disorder, Major
Exercise
Health Behavior
Behavioral Disciplines and Activities
Behavior and Behavior Mechanisms
Community Health and Preventive Medicine
Preventive Medicine
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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.Source
Ment Health Phys Act. 2011 Jun 1;4(1):13-21. Link to article on publisher's websiteDOI
10.1016/j.mhpa.2011.04.001Permanent Link to this Item
http://hdl.handle.net/20.500.14038/44732PubMed ID
21765864Related Resources
Link to article in PubMedae974a485f413a2113503eed53cd6c53
10.1016/j.mhpa.2011.04.001
Scopus Count
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