Intervention Study of Depression in Breast Cancer Patients

NCT01256008 | Completed Results DMC

• 1 other identifier: 2009BAI77B06-3
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Depression; Anxiety

Keywords

Breast Cancer; Depression; Anxiety; Cognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HAMD-17)

  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

  baseline,2 w,4 w,8 w,12 w,16 w,24 w

• Hamilton Anxiety Scale (HAMA-14)

  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.

  baseline,2 w,4 w,8 w,12 w,16 w,24 w

Secondary Outcomes (3)

• Visual Analogue Scale (VAS)

  baseline,4 w,8 w,12 w,24 w

• Athens Insomnia Scale(AIS)

  baseline, 4w,8w,12w,24w

• Functional Assessment of Cancer Treatment (FACT-B)

  baseline, 4w,12w,24w

Study Arms (3)

stage 1 Clinical Management

PLACEBO COMPARATOR

The group will receive clinical management treatment only each session.

Behavioral: Clinical Management

stage1 CBT

EXPERIMENTAL

The experimental group will receive CBT

Behavioral: CBT

stage1 Control group

NO INTERVENTION

Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.

Interventions

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.

Also known as: cognitive-behavioral intervention, psychological intervention

stage1 CBT

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.

Also known as: Placebo of Cognitive-Behavioral therapy

stage 1 Clinical Management

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Anxiety Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Wenzhou Medical University

hjc@wmu.edu.cn

+86 0577 55579363

Study Officials

• Jin C He, MD

  Wenzhou Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 1, 2015
• Results First Posted: April 10, 2015

Record last verified: 2015-04

Locations

CN (1)