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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630512
• Other study ID #: METIS
• Status: Completed
• Phase: N/A
• Start date: May 2011

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	change in generalized anxiety	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
Secondary	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
Secondary	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
Secondary	change in glycemic control	glycemic control will be indicated with HbA1c values	change from baseline in glycemic control at post-treatment
Secondary	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