Early Identification and Early Warning of Psychological Problems in Breast Cancer Patients, and Intervention Study Using Cognitive Behavioral Therapy on Depression in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HAMD-17)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.
详细描述
Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week, multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral therapy. This study tries to evaluate the efficacy of sequential therapy on breast cancer patients' depression and its improvement on breast cancer patients' life quality, pain and sleeping.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20-65 years;
- •Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
- •A week after breast cancer surgery;
- •With complaints and symptoms of depression or anxiety
- •HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;
- •Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
- •Informed consent
排除标准
- •Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
- •Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
- •Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
- •Hearing, visual or understanding impairment;
- •Severe depression, suicidal tendencies;
- •Can not or will not comply with clinical treatment programs based on the physicians' judgment
- •Exit criteria:
- •Persons with poor compliance during the trial period;
- •Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
- •Persons who are believed have other circumstances and should be suspended by Physicians
结局指标
主要结局
Hamilton Depression Rating Scale (HAMD-17)
时间窗: baseline,2 w,4 w,8 w,12 w,16 w,24 w
1. The scale(HAMD-17) is used to assessed the depression symptoms of patients. 2. The scale range is 0-53.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week
Hamilton Anxiety Scale (HAMA-14)
时间窗: baseline,2 w,4 w,8 w,12 w,16 w,24 w
1. The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. 2. The scale range is 0-56.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.
次要结局
- Visual Analogue Scale (VAS)(baseline,4 w,8 w,12 w,24 w)
- Athens Insomnia Scale(AIS)(baseline, 4w,8w,12w,24w)
- Functional Assessment of Cancer Treatment (FACT-B)(baseline, 4w,12w,24w)
研究者
Jincai He
Study Chair
Wenzhou Medical University