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

December 6, 2010
April 9, 2015
December 2010
December 2012   (final data collection date for primary outcome measure)
  • 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.
Change from Baseline in Depression and Anxiety at 24 weeks, Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Scale (HAMA) [ Time Frame: the 1st, 4th, 8th, 12th,16th and24th week ] [ Designated as safety issue: Yes ]

Evaluation Criteria:

Clinical recovery: After treatment, HAMD-17≤7 points and HAMA ≤7 points, the symptoms disappeared; Markedly: after treatment, total reduction rate of HAMD-17 or HAMA ≥ 75%, symptoms improved significantly; Effective: After treatment, compared to baseline, total reduction rate of HAMD-17 or HAMA≥50%, symptoms improved; Invalid: After treatment, total reduction rate of HAMD-17 or HAMA<50%, no improvement of symptoms. Note: Total reduction rate = [(pre-treatment score - post-treatment score) / baseline score] × 100%

Complete list of historical versions of study NCT01256008 on ClinicalTrials.gov Archive Site
  • 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.
Hospital Anxiety and Depression Scale (HAD), Quality of Life (FACT-B), well-being index, pain score, Athens Insomnia Scale [ Time Frame: the 4th and the 12th week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intervention Study of Depression in Breast Cancer Patients
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Breast Cancer
  • Depression
  • Anxiety
  • 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
  • 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
  • Placebo Comparator: stage 1 Clinical Management
    The group will receive clinical management treatment only each session.
    Intervention: Behavioral: Clinical Management
  • Experimental: stage1 CBT
    The experimental group will receive CBT
    Intervention: Behavioral: CBT
  • No Intervention: stage1 Control group
    Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01256008
2009BAI77B06-3
Yes
Jincai He, Wenzhou Medical University
Wenzhou Medical University
  • Anhui Medical University
  • Central South University
  • Harbin Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Wuhan University
Study Chair: Jin C He, MD Wenzhou Medical University
Wenzhou Medical University
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP