Intervention Study of Depression in Breast Cancer Patients

Wenzhou Medical University

Status: Completed

Conditions: Breast Cancer; Depression; Anxiety

Treatments: Behavioral: Clinical Management; Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01256008

2009BAI77B06-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 392 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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392 participants in 3 patient groups, including a placebo group

stage 1 Clinical Management

Placebo Comparator group

Description:

The group will receive clinical management treatment only each session.

Treatment:

Behavioral: Clinical Management

stage1 CBT

Experimental group

Description:

The experimental group will receive CBT

Treatment:

Behavioral: CBT

stage1 Control group

No Intervention group

Description:

Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.