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.

Study Overview

• Status: Completed
• Conditions: Depression; Breast Cancer; Anxiety
• Intervention / Treatment: Behavioral: Clinical Management; Behavioral: CBT

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 Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HAMD-17)	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	baseline,2 w,4 w,8 w,12 w,16 w,24 w
Hamilton Anxiety Scale (HAMA-14)	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.	baseline,2 w,4 w,8 w,12 w,16 w,24 w

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	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	baseline,4 w,8 w,12 w,24 w
Athens Insomnia Scale(AIS)	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	baseline, 4w,8w,12w,24w
Functional Assessment of Cancer Treatment (FACT-B)	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.	baseline, 4w,12w,24w

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Collaborators: Wuhan University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Central South University; Harbin Medical University; Anhui Medical University
• Investigators: Study Chair: Jin C He, MD, Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Breast Cancer; Anxiety; Cognitive-Behavioral Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Skin Diseases; Mood Disorders; Neoplasms; Neoplasms by Site; Breast Diseases; Depression; Depressive Disorder; Breast Neoplasms
• Other Study ID Numbers: 2009BAI77B06-3