Intervention Study of Depression in Breast Cancer Patients

Not Applicable

Completed

Brief Summary: The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
stage 1 Clinical Management	Clinical Management	The group will receive clinical management treatment only each session.
stage1 CBT	CBT	The experimental group will receive CBT

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD-17)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	baseline,4 w,8 w,12 w,24 w	1. The scale is used to assess the pain intensity of patients. 2. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain. 3. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Athens Insomnia Scale(AIS)	baseline, 4w,8w,12w,24w	1. The scale is used to assess the sleep quality of patients. 2. The scale range of AIS is 0-21. Higher score indicates worse sleep quality. 3. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Functional Assessment of Cancer Treatment (FACT-B)	baseline, 4w,12w,24w	1. The scale is used to assess the life quality of patients. 2. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. 3. The scale range is 0-144. Higher score indicates better life quality. 4. The scale was assessed at baseline,4 week,12 week,24 week.