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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.
This study examined whether patients’ expectations of treatment outcome predict treatment completion, homework compliance, and depressive symptom improvement in cognitive behavior therapy (CBT) and mindfulness-based cognitive therapy (MBCT). Study participants were patients with diabetes and comorbid depressive symptoms who were randomized to 8 sessions of either CBT (n = 45) or MBCT (n = 46), both individually delivered. The results showed that high outcome expectations were predictive of post-treatment depressive symptoms in CBT and MBCT, but not of early and mid-treatment symptoms. Patients’ outcome expectations predicted treatment completion in CBT and MBCT as well as homework compliance in MBCT. Homework compliance did not mediate the association between patients’ outcome expectations and post-treatment depressive symptom improvement. The findings do not support the hypothesis that patients’ expectations have an immediate impact on patients’ mental state and partially support the notion that patients are less involved in treatment when they hold low expectations for improvement.
Mindfulness and ruminative thinking have been shown to mediate the effects of mindfulness-based treatments on depressive symptoms. Yet, the dynamic interplay between these variables in daily life during mindfulness-based treatment has received little attention. The present study focuses on the sequence of daily changes taking place within individuals during a mindfulness-based treatment. Using a replicated single-subject time-series design, we examined the within-person temporal associations between day-to-day changes in mindfulness, repetitive thinking, and depressive symptoms. Study participants were six women with depressive symptoms who filled out diary questionnaires during a mindfulness-based treatment. A separate vector autoregressive (VAR) model was estimated for each participant. Changes in mindfulness and repetitive thinking preceded changes in depressive symptoms in a few of the six participants. We did not find evidence for reverse causality: changes in depressive symptoms did not predict later changes in mindfulness or repetitive thinking in any of the participants. These results are in accordance with the assumed causal chain of change underlying mindfulness-based treatments. Furthermore, all individuals showed moderate to strong concurrent (within-day) associations between the variables. Possible explanations for this finding include that change processes occur within the day or that the daily self-reports of mindfulness, repetitive thinking, and depressive symptoms overlap and reflect a common underlying state of mind.
ObjectiveCognitive Behavior Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) have shown to be effective interventions for treating depressive symptoms in patients with diabetes. However, little is known about which intervention works best for whom (i.e., moderators of efficacy). The aim of this study was to identify variables that differentially predicted response to either CBT or MBCT (i.e., prescriptive predictors).
Methods
The sample consisted of 91 adult outpatients with type 1 or type 2 diabetes and comorbid depressive symptoms (i.e., BDI-II ≥ 14) who were randomized to either individual 8-week CBT (n = 45) or individual 8-week MBCT (n = 46). Patients were followed for a year and depressive symptoms were measured at pre-treatment, post-treatment, and at 9-months follow-up. The predictive effect of demographics, depression related characteristics, and disease specific characteristics on change in depressive symptoms was assessed by means of hierarchical regression analyses.
Results
Analyses showed that education was the only factor that differentially predicted a decrease in depressive symptoms directly after the interventions. At post-treatment, individuals with higher educational attainment responded better to MBCT, as compared to CBT. Yet, this effect was not apparent at 9-months follow-up.
Conclusions
This study did not identify variables that robustly differentially predicted treatment effectiveness of CBT and MBCT, indicating that both CBT and MBCT are accessible interventions that are effective for treating depressive symptoms in broad populations with diabetes. More research is needed to guide patient-treatment matching in clinical practice.