Intervention Study of Depression in Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Anhui Medical University
Central South University
Harbin Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wuhan University
Information provided by (Responsible Party):
Jincai He, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01256008
First received: December 6, 2010
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: January 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Breast Cancer
Depression
Anxiety
Interventions: Behavioral: CBT
Behavioral: Clinical Management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Stage 1 Clinical Management

The group will receive clinical management treatment only each session.

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.

Stage 1 CBT

The experimental group will receive CBT each session.

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.

Stage 1 Control Group Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.

Participant Flow:   Overall Study
    Stage 1 Clinical Management     Stage 1 CBT     Stage 1 Control Group  
STARTED     98     98     196  
COMPLETED     90     91     175  
NOT COMPLETED     8     7     21  
Lost to Follow-up                 6                 4                 11  
Withdrawal by Subject                 2                 3                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stage 1 Clinical Management

The group will receive clinical management treatment only each session.

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.

stage1 CBT

The experimental group each session.

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.

stage1 Control Group Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
Total Total of all reporting groups

Baseline Measures
    Stage 1 Clinical Management     stage1 CBT     stage1 Control Group     Total  
Number of Participants  
[units: participants]
  98     98     196     392  
Age  
[units: years]
Mean (Standard Deviation)
  47.3  (8.7)     46.8  (8.9)     47.1  (8.3)     47.1  (8.6)  
Gender  
[units: participants]
       
Female     98     98     196     392  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Hamilton Depression Rating Scale (HAMD-17)   [ Time Frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w ]

2.  Primary:   Hamilton Anxiety Scale (HAMA-14)   [ Time Frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w ]

3.  Secondary:   Visual Analogue Scale (VAS)   [ Time Frame: baseline,4 w,8 w,12 w,24 w ]

4.  Secondary:   Athens Insomnia Scale(AIS)   [ Time Frame: baseline, 4w,8w,12w,24w ]

5.  Secondary:   Functional Assessment of Cancer Treatment (FACT-B)   [ Time Frame: baseline, 4w,12w,24w ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Wenzhou Medical University
phone: +86 0577 55579363
e-mail: hjc@wmu.edu.cn


No publications provided


Responsible Party: Jincai He, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01256008     History of Changes
Other Study ID Numbers: 2009BAI77B06-3
Study First Received: December 6, 2010
Results First Received: January 29, 2015
Last Updated: April 9, 2015
Health Authority: United States: Food and Drug Administration
China: Ethics Committee