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

NCT ID: NCT01630512

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31

Brief 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.

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.

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MBCT

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type: BEHAVIORAL

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

CBT

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.

Waitlist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Groningen

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robbert Sanderman, Prof. dr.

Role: STUDY_CHAIR

UMCG

Locations

UMCG

Groningen, , Netherlands

Countries

Netherlands

References

Tovote KA, Fleer J, Snippe E, Bas IV, Links TP, Emmelkamp PM, Sanderman R, Schroevers MJ. Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial. BMC Psychol. 2013 Oct 9;1(1):17. doi: 10.1186/2050-7283-1-17. eCollection 2013.

Reference Type: DERIVED

PMID: 25566369 (View on PubMed)

Other Identifiers

METIS

Identifier Type: -

Identifier Source: org_study_id