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

April 16, 2024 updated by: University Medical Center Groningen

Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

University of Groningen

Investigators

  • Study Chair: Robbert Sanderman, Prof. dr., UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimated)

June 28, 2012

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

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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