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

University Medical Center Groningen94 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Depressive Symptoms

Interventions

Mindfulness-Based Cognitive Therapy (MBCT)BEHAVIORAL

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

UMCG

Groningen, Netherlands

Outcomes

Primary Outcomes

change in severity of depressive symptoms

severity of depressive symptoms will be assessed with the Beck Depression Inventory-II

Time frame: change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months

Secondary Outcomes

change in diabetes related distress

diabetes related distress will be measured by the Problem Areas in Diabetes scale (PAID)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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