Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes.

Detailed Description
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Depression is a common co-morbidity of diabetes, negatively affecting physical performance, glycemic control, adherence to medication, and dietary, and exercise recommendations. Modalities of psychotherapy like cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) can reduce depressive symptoms in patients with medical conditions. However, proper designed randomized trials assessing and comparing effectiveness of these psychological interventions are rare. This longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in diabetes patients. Furthermore, potential moderators and mediators of treatment effect will be explored, as well as the role of common factors and treatment integrity.

Official Title
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Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus Type 1 or 2 for at least three months prior to inclusion Written informed consent Age ≥ 18 and ≤ 70 Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression) Exclusion Criteria: Not being able to read and write Dutch Severe (psychiatric) co-morbidity Acute suicidal ideations or behavior Pregnancy Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT<br> | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)<br>* The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.<br>|
| Experimental: CBT<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.<br>|
| No Intervention: Waitlist<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity of depressive symptoms | severity of depressive symptoms will be assessed with the Beck Depression Inventory-II | change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in diabetes related distress | diabetes related distress will be measured by the Problem Areas in Diabetes scale (PAID) | change from baseline in diabetes related distress at 3 months, 6 months, and 12 months | 
| change in generalized anxiety | generalized anxiety will be measured by the Generalised Anxiety Disorder Assessment (GAD 7) | change from baseline in generalized anxiety at 3 months, 6 months, and 12 months | 
| change in well-being | well-being will be measured by the Well-being Index (WHO-5) | change from baseline in well-being at 3 months, 6 months, and 12 months | 
| change in depressive symptoms | depressive symptoms will be measured by the 7-Item Hamilton Depression Rating scale (HAM-D7) | change from baseline in depressive symptoms at 3 months, 6 months, and 12 months | 
| change in glycemic control | glycemic control will be indicated with HbA1c values | change from baseline in glycemic control at post-treatment | 
| intersession changes in mood | intersession changes in mood will be assessed by the Emotion Thermometers Tool (ETT) | change in mood from the beginning of the first session to the beginning of the last session |