UMCG
Groningen, 9713 AV, Netherlands
NCT Number: NCT01630512
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Groningen, 9713 AV, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: change from baseline in glycemic control at post-treatment
glycemic control will be indicated with HbA1c values
Time frame: 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)
University Medical Center Groningen
Other
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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