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CompletedNCT01256008Updated May 1, 2015Results posted

Intervention Study of Depression in Breast Cancer Patients

An interventional study of CBT and Clinical Management in Breast Cancer, Depression and Anxiety, sponsored by Wenzhou Medical University. Completed at 1 site in China. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-01.

Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Depression
  • Anxiety

Keywords

  • Breast Cancer
  • Depression
  • Anxiety
  • Cognitive-Behavioral Therapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 392 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
392 participants (actual)

Study arms

  • Placebo comparator
    stage 1 Clinical Management

    The group will receive clinical management treatment only each session.

    Behavioral: Clinical Management

  • Experimental
    stage1 CBT

    The experimental group will receive CBT

    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.

Interventions

  • BehavioralCBT

    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

  • BehavioralClinical 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.

    Also known as: Placebo of Cognitive-Behavioral therapy

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    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

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

  2. Athens Insomnia Scale(AIS)

    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

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

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

    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.

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

07

Results

Posted Apr 10, 2015

Participant flow

Participant flow — Overall Study
MilestoneStage 1 Clinical ManagementStage 1 CBTStage 1 Control Group
Started9898196
Completed9091175
Not completed8721
Withdrew: Lost to follow-up6411
Withdrew: Withdrawal by subject2310

Outcome measures

PrimaryHamilton 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

Time frame:
baseline,2 w,4 w,8 w,12 w,16 w,24 w
Reported as:
Mean · units on a scale
Hamilton Depression Rating Scale (HAMD-17)
units on a scaleStage 1 Clinical ManagementStage 1 CBTStage 1 Control Group
baseline11.52 ± 3.78913.31 ± 5.09011.01 ± 3.844
2W10.23 ± 3.20711.72 ± 4.97610.28 ± 3.462
4W9.80 ± 3.0569.72 ± 4.83510.24 ± 3.688
8W8.71 ± 3.6017.80 ± 4.4409.42 ± 4.175
12W8.01 ± 3.2005.71 ± 3.9798.81 ± 4.198
16W7.42 ± 3.0195.13 ± 4.1088.26 ± 4.338
24W7.01 ± 3.3174.45 ± 3.8757.86 ± 4.410
SecondaryVisual Analogue Scale (VAS)

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

Time frame:
baseline,4 w,8 w,12 w,24 w
Reported as:
Mean · units on a scale
Visual Analogue Scale (VAS)
units on a scaleStage 1 Clinical Managementstage1 CBTstage1 Control Group
baseline3.23 ± 2.2403.60 ± 2.1713.31 ± 1.956
4W2.39 ± 1.9072.48 ± 2.1732.71 ± 1.806
8W2.11 ± 1.8451.89 ± 1.8992.41 ± 1.882
12W1.92 ± 1.8571.71 ± 1.7032.23 ± 2.025
24W1.71 ± 1.9821.45 ± 1.7722.04 ± 2.094
PrimaryHamilton 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.

Time frame:
baseline,2 w,4 w,8 w,12 w,16 w,24 w
Reported as:
Mean · units on a scale
Hamilton Anxiety Scale (HAMA-14)
units on a scaleStage 1 Clinical ManagementStage 1 CBTStage 1 Control Group
baseline12.11 ± 3.18813.38 ± 4.88311.37 ± 2.736
2W10.89 ± 3.40111.34 ± 4.43310.63 ± 3.105
4W10.34 ± 3.5059.82 ± 3.95210.40 ± 3.663
8W9.15 ± 3.7098.26 ± 4.1209.36 ± 3.802
12W8.57 ± 3.3646.30 ± 3.5188.81 ± 4.231
16W7.90 ± 3.2635.42 ± 3.6388.31 ± 4.348
24W7.60 ± 3.3054.99 ± 3.2637.91 ± 4.277
SecondaryAthens Insomnia Scale(AIS)

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

Time frame:
baseline, 4w,8w,12w,24w
Reported as:
Mean · units on a scale
Athens Insomnia Scale(AIS)
units on a scaleStage 1 Clinical Managementstage1 CBTstage1 Control Group
baseline6.95 ± 4.3378.49 ± 4.3417.14 ± 4.475
4W6.06 ± 3.8655.37 ± 3.2686.19 ± 4.235
8W5.87 ± 4.4144.22 ± 3.2365.99 ± 4.507
12W5.63 ± 4.3352.90 ± 2.2425.85 ± 4.749
24W5.34 ± 4.5052.40 ± 2.0545.63 ± 4.946
SecondaryFunctional Assessment of Cancer Treatment (FACT-B)

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.

Time frame:
baseline, 4w,12w,24w
Reported as:
Mean · units on a scale
Functional Assessment of Cancer Treatment (FACT-B)
units on a scaleStage 1 Clinical Managementstage1 CBTstage1 Control Group
baseline78.09 ± 18.8676.78 ± 19.9179.49 ± 21.06
4W80.41 ± 19.1486.67 ± 18.7480.07 ± 22.04
12W89.69 ± 16.22102.94 ± 20.2485.14 ± 24.61
24W95.06 ± 17.54109.21 ± 19.6289.70 ± 25.76

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stage 1 Clinical Management—0/98 (0%)0/98 (0%)
stage1 CBT—0/98 (0%)0/98 (0%)
stage1 Control Group—0/196 (0%)0/196 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Stage 1 Clinical Managementstage1 CBTstage1 Control GroupTotal
Mean47.3 ± 8.746.8 ± 8.947.1 ± 8.347.1 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Stage 1 Clinical Managementstage1 CBTstage1 Control GroupTotal
Female9898196392
Male0000
08

Study locations

1 site
  • Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01256008
Lead sponsor
Wenzhou Medical University
Collaborators
Anhui Medical University, Central South University, Harbin Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan University
Responsible party
Jincai He (Study Chair, Wenzhou Medical University) — Principal investigator
First posted
Dec 8, 2010
Start date
Dec 2010
Primary completion
Dec 2012
Completion
Feb 2013
Results posted
Apr 10, 2015
Last update
May 1, 2015

Study contacts

Jin C He, MD
study chair · Wenzhou Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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