Intervention Study of Depression in Breast Cancer Patients

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

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Depression, Anxiety

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: Clinical Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: stage 1 Clinical Management<br>The group will receive clinical management treatment only each session. | Behavioral: Clinical Management<br>* Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention. Following are major elements: Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.<br>* Other names: Placebo of Cognitive-Behavioral therapy;|
| Experimental: stage1 CBT<br>The experimental group will receive CBT | Behavioral: CBT<br>* The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.<br>* Other names: psychological intervention;|
| No Intervention: stage1 Control group<br>Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD-17) | The scale(HAMD-17) is used to assessed the depression symptoms of patients. The scale range is 0-53.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week | baseline,2 w,4 w,8 w,12 w,16 w,24 w | 
| Hamilton Anxiety Scale (HAMA-14) | The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. The scale range is 0-56.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week. | baseline,2 w,4 w,8 w,12 w,16 w,24 w | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy