Trial Outcomes & Findings for Intervention Study of Depression in Breast Cancer Patients (NCT NCT01256008)
NCT ID: NCT01256008
Last Updated: 2015-05-01
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
392 participants
Primary outcome timeframe
baseline,2 w,4 w,8 w,12 w,16 w,24 w
Results posted on
2015-05-01
Participant Flow
Participant milestones
| Measure |
Stage 1 Clinical Management
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
The experimental group will receive CBT each session.
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.
|
Stage 1 Control Group
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
196
|
|
Overall Study
COMPLETED
|
90
|
91
|
175
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
21
|
Reasons for withdrawal
| Measure |
Stage 1 Clinical Management
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
The experimental group will receive CBT each session.
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.
|
Stage 1 Control Group
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
10
|
Baseline Characteristics
Intervention Study of Depression in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
stage1 CBT
n=98 Participants
The experimental group each session.
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.
|
stage1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline,2 w,4 w,8 w,12 w,16 w,24 w1. 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
Outcome measures
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
n=98 Participants
The experimental group will receive CBT each session.
CBT and clinical management: 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.
|
Stage 1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Hamilton Depression Rating Scale (HAMD-17)
baseline
|
11.52 units on a scale
Standard Deviation 3.789
|
13.31 units on a scale
Standard Deviation 5.090
|
11.01 units on a scale
Standard Deviation 3.844
|
|
Hamilton Depression Rating Scale (HAMD-17)
2W
|
10.23 units on a scale
Standard Deviation 3.207
|
11.72 units on a scale
Standard Deviation 4.976
|
10.28 units on a scale
Standard Deviation 3.462
|
|
Hamilton Depression Rating Scale (HAMD-17)
4W
|
9.80 units on a scale
Standard Deviation 3.056
|
9.72 units on a scale
Standard Deviation 4.835
|
10.24 units on a scale
Standard Deviation 3.688
|
|
Hamilton Depression Rating Scale (HAMD-17)
8W
|
8.71 units on a scale
Standard Deviation 3.601
|
7.80 units on a scale
Standard Deviation 4.440
|
9.42 units on a scale
Standard Deviation 4.175
|
|
Hamilton Depression Rating Scale (HAMD-17)
12W
|
8.01 units on a scale
Standard Deviation 3.200
|
5.71 units on a scale
Standard Deviation 3.979
|
8.81 units on a scale
Standard Deviation 4.198
|
|
Hamilton Depression Rating Scale (HAMD-17)
16W
|
7.42 units on a scale
Standard Deviation 3.019
|
5.13 units on a scale
Standard Deviation 4.108
|
8.26 units on a scale
Standard Deviation 4.338
|
|
Hamilton Depression Rating Scale (HAMD-17)
24W
|
7.01 units on a scale
Standard Deviation 3.317
|
4.45 units on a scale
Standard Deviation 3.875
|
7.86 units on a scale
Standard Deviation 4.410
|
PRIMARY outcome
Timeframe: baseline,2 w,4 w,8 w,12 w,16 w,24 w1. 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.
Outcome measures
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
n=98 Participants
The experimental group will receive CBT each session.
CBT and clinical management: 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.
|
Stage 1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Hamilton Anxiety Scale (HAMA-14)
baseline
|
12.11 units on a scale
Standard Deviation 3.188
|
13.38 units on a scale
Standard Deviation 4.883
|
11.37 units on a scale
Standard Deviation 2.736
|
|
Hamilton Anxiety Scale (HAMA-14)
2W
|
10.89 units on a scale
Standard Deviation 3.401
|
11.34 units on a scale
Standard Deviation 4.433
|
10.63 units on a scale
Standard Deviation 3.105
|
|
Hamilton Anxiety Scale (HAMA-14)
4W
|
10.34 units on a scale
Standard Deviation 3.505
|
9.82 units on a scale
Standard Deviation 3.952
|
10.40 units on a scale
Standard Deviation 3.663
|
|
Hamilton Anxiety Scale (HAMA-14)
8W
|
9.15 units on a scale
Standard Deviation 3.709
|
8.26 units on a scale
Standard Deviation 4.120
|
9.36 units on a scale
Standard Deviation 3.802
|
|
Hamilton Anxiety Scale (HAMA-14)
12W
|
8.57 units on a scale
Standard Deviation 3.364
|
6.30 units on a scale
Standard Deviation 3.518
|
8.81 units on a scale
Standard Deviation 4.231
|
|
Hamilton Anxiety Scale (HAMA-14)
16W
|
7.90 units on a scale
Standard Deviation 3.263
|
5.42 units on a scale
Standard Deviation 3.638
|
8.31 units on a scale
Standard Deviation 4.348
|
|
Hamilton Anxiety Scale (HAMA-14)
24W
|
7.60 units on a scale
Standard Deviation 3.305
|
4.99 units on a scale
Standard Deviation 3.263
|
7.91 units on a scale
Standard Deviation 4.277
|
SECONDARY outcome
Timeframe: baseline,4 w,8 w,12 w,24 w1. 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
Outcome measures
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
n=98 Participants
The experimental group will receive CBT each session.
CBT and clinical management: 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.
|
Stage 1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Visual Analogue Scale (VAS)
baseline
|
3.23 units on a scale
Standard Deviation 2.240
|
3.60 units on a scale
Standard Deviation 2.171
|
3.31 units on a scale
Standard Deviation 1.956
|
|
Visual Analogue Scale (VAS)
4W
|
2.39 units on a scale
Standard Deviation 1.907
|
2.48 units on a scale
Standard Deviation 2.173
|
2.71 units on a scale
Standard Deviation 1.806
|
|
Visual Analogue Scale (VAS)
8W
|
2.11 units on a scale
Standard Deviation 1.845
|
1.89 units on a scale
Standard Deviation 1.899
|
2.41 units on a scale
Standard Deviation 1.882
|
|
Visual Analogue Scale (VAS)
12W
|
1.92 units on a scale
Standard Deviation 1.857
|
1.71 units on a scale
Standard Deviation 1.703
|
2.23 units on a scale
Standard Deviation 2.025
|
|
Visual Analogue Scale (VAS)
24W
|
1.71 units on a scale
Standard Deviation 1.982
|
1.45 units on a scale
Standard Deviation 1.772
|
2.04 units on a scale
Standard Deviation 2.094
|
SECONDARY outcome
Timeframe: baseline, 4w,8w,12w,24w1. 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
Outcome measures
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
n=98 Participants
The experimental group will receive CBT each session.
CBT and clinical management: 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.
|
Stage 1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Athens Insomnia Scale(AIS)
baseline
|
6.95 units on a scale
Standard Deviation 4.337
|
8.49 units on a scale
Standard Deviation 4.341
|
7.14 units on a scale
Standard Deviation 4.475
|
|
Athens Insomnia Scale(AIS)
4W
|
6.06 units on a scale
Standard Deviation 3.865
|
5.37 units on a scale
Standard Deviation 3.268
|
6.19 units on a scale
Standard Deviation 4.235
|
|
Athens Insomnia Scale(AIS)
8W
|
5.87 units on a scale
Standard Deviation 4.414
|
4.22 units on a scale
Standard Deviation 3.236
|
5.99 units on a scale
Standard Deviation 4.507
|
|
Athens Insomnia Scale(AIS)
12W
|
5.63 units on a scale
Standard Deviation 4.335
|
2.90 units on a scale
Standard Deviation 2.242
|
5.85 units on a scale
Standard Deviation 4.749
|
|
Athens Insomnia Scale(AIS)
24W
|
5.34 units on a scale
Standard Deviation 4.505
|
2.40 units on a scale
Standard Deviation 2.054
|
5.63 units on a scale
Standard Deviation 4.946
|
SECONDARY outcome
Timeframe: baseline, 4w,12w,24w1. 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.
Outcome measures
| Measure |
Stage 1 Clinical Management
n=98 Participants
The group will receive clinical management treatment only each session.
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.
|
Stage 1 CBT
n=98 Participants
The experimental group will receive CBT each session.
CBT and clinical management: 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.
|
Stage 1 Control Group
n=196 Participants
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
|
|---|---|---|---|
|
Functional Assessment of Cancer Treatment (FACT-B)
baseline
|
78.09 units on a scale
Standard Deviation 18.86
|
76.78 units on a scale
Standard Deviation 19.91
|
79.49 units on a scale
Standard Deviation 21.06
|
|
Functional Assessment of Cancer Treatment (FACT-B)
4W
|
80.41 units on a scale
Standard Deviation 19.14
|
86.67 units on a scale
Standard Deviation 18.74
|
80.07 units on a scale
Standard Deviation 22.04
|
|
Functional Assessment of Cancer Treatment (FACT-B)
12W
|
89.69 units on a scale
Standard Deviation 16.22
|
102.94 units on a scale
Standard Deviation 20.24
|
85.14 units on a scale
Standard Deviation 24.61
|
|
Functional Assessment of Cancer Treatment (FACT-B)
24W
|
95.06 units on a scale
Standard Deviation 17.54
|
109.21 units on a scale
Standard Deviation 19.62
|
89.70 units on a scale
Standard Deviation 25.76
|
Adverse Events
Stage 1 Clinical Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
stage1 CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
stage1 Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Wenzhou Medical University
Phone: +86 0577 55579363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place