Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 192
- 试验地点
- 1
- 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 after cancer
详细描述
Cancer patients are prone to develop depressive symptoms, even after curative treatment. Conventional therapies such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are frequently used for reducing these depressive symptoms in patients with medical conditions. However, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. Therefore, our longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in cancer survivors. In addition, potential moderators and mediators of each intervention will be explored.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Completion of curative cancer treatment (for primary diagnosis of cancer or possible recurrence of cancer) at least one year ago and no longer than five years ago.
- •Currently no active cancer.
- •≥ 18 at the time of diagnosis of cancer and ≤ 75 at inclusion.
- •Depressive symptoms as assessed by a Patient Health Questionnaire (PHQ-9) score ≥ 10 (indicating presence of at least mild depressive symptoms).
- •Being able to read, write, and speak Dutch.
排除标准
- •Severe psychiatric co-morbidity (i.e. acute suicidal ideations or behavior, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems).
- •Receiving psychological treatment for depressive symptoms, currently or less than two months prior to study participation.
- •Unstable antidepressant medication regimen two months prior to inclusion of the study
结局指标
主要结局
Change in severity of depressive symptoms
时间窗: pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up
Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)
次要结局
- Change in generalized anxiety(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in well-being(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in fatigue(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
- Change in fear of recurrence(pre-treatment (baseline) to post-treatment (approximately 3 months after baseline) and 3- and 9-month follow-up)
研究者
Maya Schroevers
Dr. M. Schroevers
University Medical Center Groningen