Clinical trial NCT01256008: Intervention Study of Depression in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Depression
Anxiety
Keywords: Breast Cancer
Depression
Anxiety
Cognitive-Behavioral Therapy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Anhui Medical University
name: Central South University
name: Harbin Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wuhan University
First posted: 2010-12-08
Enrollment: 392
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAMD-17)
timeFrame: baseline,2 w,4 w,8 w,12 w,16 w,24 w
measure: Hamilton Anxiety Scale (HAMA-14)
timeFrame: baseline,2 w,4 w,8 w,12 w,16 w,24 w
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline,4 w,8 w,12 w,24 w
measure: Athens Insomnia Scale(AIS)
timeFrame: baseline, 4w,8w,12w,24w
measure: Functional Assessment of Cancer Treatment (FACT-B)
timeFrame: baseline, 4w,12w,24w
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Jin C He, MD
role: STUDY_CHAIR
References: