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| Name | Class |
|---|---|
| University of Groningen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT | Experimental |
| |
| CBT | Experimental |
| |
| Waitlist | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Robbert Sanderman, Prof. dr. | University Medical Center Groningen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Groningen | 9713 AV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25566369 | Derived | Tovote KA, Fleer J, Snippe E, Bas IV, Links TP, Emmelkamp PM, Sanderman R, Schroevers MJ. Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial. BMC Psychol. 2013 Oct 9;1(1):17. doi: 10.1186/2050-7283-1-17. eCollection 2013. |
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| 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. |
|
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 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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