title: Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial.
abstract: BACKGROUND
  Depressive 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials NCT01630512.
authors.affiliation: Department of Health Sciences, Section Health Psychology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: K Annika
authors.initials: KA
authors.lastname: Tovote
authors.affiliation: Department of Health Sciences, Section Health Psychology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Joke
authors.initials: J
authors.lastname: Fleer
authors.affiliation: Department of Health Sciences, Section Health Psychology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Evelien
authors.initials: E
authors.lastname: Snippe
authors.affiliation: Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Irina V
authors.initials: IV
authors.lastname: Bas
authors.affiliation: Department of Endocrinology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Thera P
authors.initials: TP
authors.lastname: Links
authors.affiliation: Department of Clinical Psychology, University of Amsterdam, Amsterdam, the Netherlands ; The Center for Social and Humanities Research, King AbdulAziz University, Jeddah, Saudi Arabia.
authors.forename: Paul Mg
authors.initials: PM
authors.lastname: Emmelkamp
authors.affiliation: Department of Health Sciences, Section Health Psychology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Robbert
authors.initials: R
authors.lastname: Sanderman
authors.affiliation: Department of Health Sciences, Section Health Psychology, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Maya J
authors.initials: MJ
authors.lastname: Schroevers
keywords: Cognitive behavioral therapy; Depression; Diabetes; Intervention; Mindfulness; Randomized controlled trial; Treatment