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临床试验/NCT02314390
NCT02314390已完成不适用

Group- Versus Individual-Mindfulness-Based Cognitive Therapy for Patients With a Chronic Somatic Disease and Comorbid Depressive Symptoms: a Randomized Trial

University Medical Center Groningen0 个研究点目标入组 56 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
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 both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease.

详细描述

Depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. In recent years, Mindfulness-Based Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. Usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of MBCT as an individual training.

This pilot study aims to compare the effectiveness and feasibility of group and individual MBCT in reducing depressive symptoms in patients with a chronic somatic disease.

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
None

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

入选标准

  • Chronic somatic disease
  • 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
  • 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: Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up

Severity of depressive symptoms are assessed with the Beck Depression Inventory-II

次要结局

  • Change in generalized anxiety(Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up)
  • Change in well-being(Pre-treatment to post-treatment (primary measurement point; approximately 3 months after pre-treatment) and 3-months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maya Schroevers

PhD

University Medical Center Groningen

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