Intervention Study of Depression in Breast Cancer Patients
NCT01256008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392
Last updated 2015-05-01
Summary
The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.
Conditions
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Anhui Medical University
collaborator OTHER -
Central South University
collaborator OTHER -
Harbin Medical University
collaborator OTHER -
Second Affiliated Hospital, School of Medicine, Zhejiang University
collaborator OTHER -
Wuhan University
collaborator OTHER -
Wenzhou Medical University
lead OTHER
Principal Investigators
-
Jin C He, MD · Wenzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-02-28
Countries
- China
Study Locations
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