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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630512
First Posted: June 28, 2012
Last Update Posted: September 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Groningen
Information provided by (Responsible Party):
Annika Tovote, MSc, University Medical Centre Groningen
  Purpose
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.

Condition Intervention
Depressive Symptoms Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) Behavioral: Cognitive Behavioral Therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial

Further study details as provided by Annika Tovote, MSc, University Medical Centre Groningen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 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 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 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 in glycemic control [ Time Frame: change from baseline in glycemic control at post-treatment ]
    glycemic control will be indicated with HbA1c values

  • 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)


Enrollment: 94
Study Start Date: May 2011
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBCT Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
Experimental: CBT Behavioral: Cognitive 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.
No Intervention: Waitlist

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630512


Locations
Netherlands
UMCG
Groningen, Netherlands, 9713 AV
Sponsors and Collaborators
University Medical Center Groningen
University of Groningen
Investigators
Study Chair: Robbert Sanderman, Prof. dr. UMCG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annika Tovote, MSc, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01630512     History of Changes
Other Study ID Numbers: METIS
First Submitted: June 15, 2012
First Posted: June 28, 2012
Last Update Posted: September 11, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Depression
Behavioral Symptoms