title: Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder.
abstract: 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.
authors.affiliation: Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA USA.
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Schneider
authors.forename: Sherry L
authors.initials: SL
authors.lastname: Pagoto
authors.forename: Barbara
authors.initials: B
authors.lastname: Handschin
authors.forename: Emily
authors.initials: E
authors.lastname: Panza
authors.forename: Susan
authors.initials: S
authors.lastname: Bakke
authors.forename: Qin
authors.initials: Q
authors.lastname: Liu
authors.forename: Mihaela
authors.initials: M
authors.lastname: Blendea
authors.forename: Ira S
authors.initials: IS
authors.lastname: Ockene
authors.forename: Yunsheng
authors.initials: Y
authors.lastname: Ma