Intervention Study of Depression in Breast Cancer Patients
NCT ID: NCT01256008
Last Updated: 2015-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
392 participants
INTERVENTIONAL
2010-12-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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stage 1 Clinical Management
The group will receive clinical management treatment only each session.
Clinical Management
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.
stage1 CBT
The experimental group will receive CBT
CBT
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.
stage1 Control group
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
No interventions assigned to this group
Interventions
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CBT
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.
Clinical Management
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
65 Years
FEMALE
No
Sponsors
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Anhui Medical University
OTHER
Central South University
OTHER
Harbin Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Wuhan University
OTHER
Wenzhou Medical University
OTHER
Responsible Party
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Jincai He
Study Chair
Principal Investigators
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Jin C He, MD
Role: STUDY_CHAIR
Wenzhou Medical University
Locations
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Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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2009BAI77B06-3
Identifier Type: -
Identifier Source: org_study_id
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