- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630512
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Groningen, Netherlands, 9713 AV
- UMCG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist
|
|
Experimental: CBT
|
The intervention consists of 8 weekly individual sessions of CBT.
Each session will be administered individually and will last 45 to 60 minutes.
|
Experimental: MBCT
|
The intervention consists of 8 weekly individual sessions of MBCT.
Each session will be administered individually and will last 45 to 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in severity of depressive symptoms
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
|
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
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)
|
change from baseline in diabetes related distress at 3 months, 6 months, and 12 months
|
change in generalized anxiety
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)
|
change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
|
change in well-being
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)
|
change from baseline in well-being at 3 months, 6 months, and 12 months
|
change in depressive symptoms
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)
|
change from baseline in depressive symptoms at 3 months, 6 months, and 12 months
|
change in glycemic control
Time Frame: change from baseline in glycemic control at post-treatment
|
glycemic control will be indicated with HbA1c values
|
change from baseline in glycemic control at post-treatment
|
intersession changes in mood
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)
|
change in mood from the beginning of the first session to the beginning of the last session
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robbert Sanderman, Prof. dr., UMCG
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METIS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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