Depressive Symptoms
Conditions
Brief summary
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
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.
Interventions
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
BEHAVIORALCognitive Behavioral Therapy (CBT)
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.
Sponsors
University of Groningen
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in severity of depressive symptoms | change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months | severity of depressive symptoms will be assessed with the Beck Depression Inventory-II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in generalized anxiety | change from baseline in generalized anxiety at 3 months, 6 months, and 12 months | generalized anxiety will be measured by the Generalised Anxiety Disorder Assessment (GAD 7) |
| change in well-being | change from baseline in well-being at 3 months, 6 months, and 12 months | well-being will be measured by the Well-being Index (WHO-5) |
| change in diabetes related distress | change from baseline in diabetes related distress at 3 months, 6 months, and 12 months | diabetes related distress will be measured by the Problem Areas in Diabetes scale (PAID) |
| change in glycemic control | change from baseline in glycemic control at post-treatment | glycemic control will be indicated with HbA1c values |
| intersession changes in mood | change in mood from the beginning of the first session to the beginning of the last session | intersession changes in mood will be assessed by the Emotion Thermometers Tool (ETT) |
| change in depressive symptoms | change from baseline in depressive symptoms at 3 months, 6 months, and 12 months | depressive symptoms will be measured by the 7-Item Hamilton Depression Rating scale (HAM-D7) |
Countries
Netherlands
Outcome results
None listed