Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients
This study is currently recruiting participants.
Verified November 2012 by University Medical Centre Groningen
Sponsor:
University Medical Centre Groningen
Information provided by (Responsible Party):
Annika Tovote, MSc, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01630512
First received: June 15, 2012
Last updated: November 19, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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)
| Estimated Enrollment: | 126 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630512
Locations
| Netherlands | |
| UMCG | Recruiting |
| Groningen, Netherlands, 9713 AV | |
| Contact: Annika Tovote, MSc 0031 (0)50 363 2955 K.A.Tovote@umcg.no | |
| Contact: Evelien Snippe, MSc 0031 (0)50 363 2945 E.Snippe@med.umcg.nl | |
Sponsors and Collaborators
University Medical Centre 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: | November 19, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013