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
  Purpose

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


Condition Intervention
Breast Cancer
Depression
Anxiety
Behavioral: CBT
Behavioral: Clinical Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w ] [ Designated as safety issue: No ]
    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

  • Hamilton Anxiety Scale (HAMA-14) [ Time Frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w ] [ Designated as safety issue: No ]
    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:
  • Visual Analogue Scale (VAS) [ Time Frame: baseline,4 w,8 w,12 w,24 w ] [ Designated as safety issue: No ]
    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

  • Athens Insomnia Scale(AIS) [ Time Frame: baseline, 4w,8w,12w,24w ] [ Designated as safety issue: No ]
    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

  • Functional Assessment of Cancer Treatment (FACT-B) [ Time Frame: baseline, 4w,12w,24w ] [ Designated as safety issue: No ]
    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.


Enrollment: 392
Study Start Date: December 2010
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jincai He, Study Chair, 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

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

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

ClinicalTrials.gov processed this record on May 21, 2015