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BackgroundDepressive symptoms are a common problem in patients with diabetes, laying an additional burden on both the patients and the health care system. Patients suffering from these symptoms rarely receive adequate evidence-based psychological help as part of routine clinical care. Offering brief evidence-based treatments aimed at alleviating depressive symptoms could improve patients’ medical and psychological outcomes. However, well-designed trials focusing on the effectiveness of psychological treatments for depressive symptoms in patients with diabetes are scarce. The Mood Enhancement Therapy Intervention Study (METIS) tests the effectiveness of two treatment protocols in patients with diabetes. Individually administered Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) are compared with a waiting list control condition in terms of their effectiveness in reducing the severity of depressive symptoms. Furthermore, we explore several potential moderators and mediators of change underlying treatment effectiveness, as well as the role of common factors and treatment integrity. Methods/design The METIS trial has a randomized controlled design with three arms, comparing CBT and MBCT with a waiting list control condition. Intervention groups receive treatment immediately; the waiting list control group receives treatment three months later. Both treatments are individually delivered in 8 sessions of 45 to 60 minutes by trained therapists. Primary outcome is severity of depressive symptoms. Anxiety, well-being, diabetes-related distress, HbA1c levels, and intersession changes in mood are assessed as secondary outcomes. Assessments are held at pre-treatment, several time points during treatment, at post-treatment, and at 3-months and 9-months follow-up. The study has been approved by a medical ethical committee. Discussion Both CBT and MBCT are expected to help improve depressive symptoms in patients with diabetes. If MBCT is at least equally effective as CBT, MBCT can be established as an alternative approach to CBT for treating depressive symptoms in patients with diabetes. By analyzing moderators and mediators of change, more information can be gathered for whom and why CBT and MBCT are effective.
OBJECTIVE Depression is a common comorbidity of diabetes, undesirably affecting patients’ physical and mental functioning. Psychological interventions are effective treatments for depression in the general population as well as in patients with a chronic disease. The aim of this study was to assess the efficacy of individual mindfulness-based cognitive therapy (MBCT) and individual cognitive behavior therapy (CBT) in comparison with a waiting-list control condition for treating depressive symptoms in adults with type 1 or type 2 diabetes.RESEARCH DESIGN AND METHODS In this randomized controlled trial, 94 outpatients with diabetes and comorbid depressive symptoms (i.e., Beck Depression Inventory-II [BDI-II] ≥14) were randomized to MBCT (n = 31), CBT (n = 32), or waiting list (n = 31). All participants completed written questionnaires and interviews at pre- and postmeasurement (3 months later). Primary outcome measure was severity of depressive symptoms (BDI-II and Toronto Hamilton Depression Rating Scale). Anxiety (Generalized Anxiety Disorder 7), well-being (Well-Being Index), diabetes-related distress (Problem Areas In Diabetes), and HbA1c levels were assessed as secondary outcomes. RESULTS Results showed that participants receiving MBCT and CBT reported significantly greater reductions in depressive symptoms compared with patients in the waiting-list control condition (respectively, P = 0.004 and P < 0.001; d = 0.80 and 1.00; clinically relevant improvement 26% and 29% vs. 4%). Both interventions also had significant positive effects on anxiety, well-being, and diabetes-related distress. No significant effect was found on HbA1c values. CONCLUSIONS Both individual MBCT and CBT are effective in improving a range of psychological symptoms in individuals with type 1 and type 2 diabetes.