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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:
Collaborator:
University of Groningen
Information provided by (Responsible Party):
Annika Tovote, MSc, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01630512
First received: June 15, 2012
Last updated: September 10, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630512

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

No publications provided

Responsible Party: Annika Tovote, MSc, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01630512     History of Changes
Other Study ID Numbers: METIS
Study First Received: June 15, 2012
Last Updated: September 10, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 23, 2014