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Intervention Study of Depression in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01256008
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : April 10, 2015
Last Update Posted : May 1, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Breast Cancer Depression Anxiety Behavioral: CBT Behavioral: Clinical Management

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : December 2010
Primary Completion Date : December 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: stage 1 Clinical Management
The group will receive clinical management treatment only each session.
Behavioral: 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.

Other Name: Placebo of Cognitive-Behavioral therapy
Experimental: stage1 CBT
The experimental group will receive CBT
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.
Other Names:
  • cognitive-behavioral intervention
  • psychological intervention
No Intervention: stage1 Control group
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: baseline,4 w,8 w,12 w,24 w ]
    1. The scale is used to assess the pain intensity of patients.
    2. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.
    3. The scale was assessed at baseline,4 week,8 week,12 week,24 week

  2. Athens Insomnia Scale(AIS) [ Time Frame: baseline, 4w,8w,12w,24w ]
    1. The scale is used to assess the sleep quality of patients.
    2. The scale range of AIS is 0-21. Higher score indicates worse sleep quality.
    3. The scale was assessed at baseline,4 week,8 week,12 week,24 week

  3. Functional Assessment of Cancer Treatment (FACT-B) [ Time Frame: baseline, 4w,12w,24w ]
    1. The scale is used to assess the life quality of patients.
    2. The scale includes 5 subscales. The scores of each scale are summed to compute a total score.
    3. The scale range is 0-144. Higher score indicates better life quality.
    4. The scale was assessed at baseline,4 week,12 week,24 week.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256008


Locations
China, Zhejiang
Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Anhui Medical University
Central South University
Harbin Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wuhan University
Investigators
Study Chair: Jin C He, MD Wenzhou Medical University
More Information

Responsible Party: Jincai He, Study Chair, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01256008     History of Changes
Other Study ID Numbers: 2009BAI77B06-3
First Posted: December 8, 2010    Key Record Dates
Results First Posted: April 10, 2015
Last Update Posted: May 1, 2015
Last Verified: April 2015

Keywords provided by Jincai He, Wenzhou Medical University:
Breast Cancer
Depression
Anxiety
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders