Breast Cancer | Intervention Study of Depression in Breast Cancer Patients
Breast Cancer research study
What is the primary objective of this study?
The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:CBTThe 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.
Behavioral:Clinical ManagementClinical 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
stage 1 Clinical ManagementThe group will receive clinical management treatment only each session.
stage1 CBTThe experimental group will receive CBT
stage1 Control groupParticipants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
Start Date: December 2010
Completed Date: February 2013
Primary Outcome: Hamilton Depression Rating Scale (HAMD-17)
Secondary Outcome: Visual Analogue Scale (VAS)
Study sponsors, principal investigator, and references
Principal Investigator: Jin C He, MD
Lead Sponsor: Wenzhou Medical University
Collaborator: Anhui Medical University