Status:
COMPLETED
Intervention Study of Depression in Breast Cancer Patients
Lead Sponsor:
Wenzhou Medical University
Collaborating Sponsors:
Anhui Medical University
Central South University
Conditions:
Breast Cancer
Depression
Eligibility:
FEMALE
20-65 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT01256008
Start Date
December 1 2010
End Date
February 1 2013
Last Update
May 1 2015
Active Locations (1)
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1
Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000