Intervention Study of Depression in Breast Cancer Patients

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256008
• Other study ID #: 2009BAI77B06-3
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: April 9, 2015
• Start date: December 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2015
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Wenzhou Medical University	Anhui Medical University, Central South University, Harbin Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAMD-17)	The scale(HAMD-17) is used to assessed the depression symptoms of patients.; The scale range is 0-53.Higher value represents a worse outcome.; The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week	baseline,2 w,4 w,8 w,12 w,16 w,24 w	No
Primary	Hamilton Anxiety Scale (HAMA-14)	The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.; The scale range is 0-56.Higher value represents a worse outcome.; The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.	baseline,2 w,4 w,8 w,12 w,16 w,24 w	No
Secondary	Visual Analogue Scale (VAS)	The scale is used to assess the pain intensity of patients.; The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.; The scale was assessed at baseline,4 week,8 week,12 week,24 week	baseline,4 w,8 w,12 w,24 w	No
Secondary	Athens Insomnia Scale(AIS)	The scale is used to assess the sleep quality of patients.; The scale range of AIS is 0-21. Higher score indicates worse sleep quality.; The scale was assessed at baseline,4 week,8 week,12 week,24 week	baseline, 4w,8w,12w,24w	No
Secondary	Functional Assessment of Cancer Treatment (FACT-B)	The scale is used to assess the life quality of patients.; The scale includes 5 subscales. The scores of each scale are summed to compute a total score.; The scale range is 0-144. Higher score indicates better life quality.; The scale was assessed at baseline,4 week,12 week,24 week.	baseline, 4w,12w,24w	No