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Completed

NCT Number: NCT01256008

Intervention Study of 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.

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Key information

Conditions

Breast Cancer Anxiety Anxiety Disorders Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Depression Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

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

Clinical management

Behavioral

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 names: Placebo of Cognitive-Behavioral therapy

Primary outcomes

  1. Hamilton Depression Rating Scale (HAMD-17)

    Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w

    • 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

  2. Hamilton Anxiety Scale (HAMA-14)

    Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w

    • 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.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: baseline,4 w,8 w,12 w,24 w

    • 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

  2. Athens Insomnia Scale(AIS)

    Time frame: baseline, 4w,8w,12w,24w

    • 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

  3. Functional Assessment of Cancer Treatment (FACT-B)

    Time frame: baseline, 4w,12w,24w

    • 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.

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Collaborators

  • Anhui Medical University
  • Central South University
  • Harbin Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Wuhan University

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 8, 2010
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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