Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- change in severity of depressive symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
change in severity of depressive symptoms
时间窗: 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
次要结局
- change in depressive symptoms(change from baseline in depressive symptoms at 3 months, 6 months, and 12 months)
- change in generalized anxiety(change from baseline in generalized anxiety at 3 months, 6 months, and 12 months)
- intersession changes in mood(change in mood from the beginning of the first session to the beginning of the last session)
- change in diabetes related distress(change from baseline in diabetes related distress at 3 months, 6 months, and 12 months)
- change in well-being(change from baseline in well-being at 3 months, 6 months, and 12 months)
- change in glycemic control(change from baseline in glycemic control at post-treatment)