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Completed

NCT Number: NCT01630512

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMCG

Groningen, 9713 AV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based cognitive therapy (MBCT)

Behavioral

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)

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. change in glycemic control

    Time frame: change from baseline in glycemic control at post-treatment

    glycemic control will be indicated with HbA1c values

  6. 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)

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • University of Groningen

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
First posted
Jun 28, 2012
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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