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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Wenzhou Medical University
- Enrollment
- 392
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HAMD-17)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Jincai He
Study Chair
Wenzhou Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HAMD-17)
Time Frame: 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)
Time Frame: 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 Outcomes
- Visual Analogue Scale (VAS)(baseline,4 w,8 w,12 w,24 w)
- Athens Insomnia Scale(AIS)(baseline, 4w,8w,12w,24w)
- Functional Assessment of Cancer Treatment (FACT-B)(baseline, 4w,12w,24w)