Back to resultsPsycho-behavioral Intervention for Depression in Chronic Heart Failure
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Psycho-behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- between 60 -85 years old.
- male or female.
- Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
- The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
- Reading and writing competency for completing the rating scales.
- Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.
Exclusion Criteria:
- Currently taking antidepressant drugs, and drug dose is unstable.
- With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
- Intact cognitive function with CSI-D score of less than 7.
- Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
- Planned heart surgery within 9 months.
- Unable to comply with psychological intervention due to serious physical conditions -
Sites / Locations
- Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
- Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
- Beijing Chaoyang Third HospitalRecruiting
- Beijing Fengtai Tieying HospitalRecruiting
- Beijing Tiancun Community Health CenterRecruiting
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
control group
Arm Description
Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months.
Subjects will receive usual care and be contacted as same frequent as the intervention group.
Outcomes
Primary Outcome Measures
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
Secondary Outcome Measures
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms.
17-Item Hamilton Rating Scale for Depression
The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed).
Beck Depression Inventory II
The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms.
Geriatric Depression Inventory-Self-Report
The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms.
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
change of NT-ProBNP level
cardiac function
change of ejection fraction as measured with ultrasound cardiogram
Minnesota living with heart failure questionnaire
The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03233451
Brief Title
Psycho-behavioral Intervention for Depression in Chronic Heart Failure
Official Title
Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.
Detailed Description
Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Subjects will receive usual care and be contacted as same frequent as the intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-behavioral intervention
Intervention Description
The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
Primary Outcome Measure Information:
Title
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
Description
The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
Time Frame
between baseline and week 12
Secondary Outcome Measure Information:
Title
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
Description
The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms.
Time Frame
between baseline and week 1, 2, 4, 8, 24 and 36
Title
17-Item Hamilton Rating Scale for Depression
Description
The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed).
Time Frame
between baseline and week 4, 8, 12, 24 and 36
Title
Beck Depression Inventory II
Description
The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms.
Time Frame
between baseline and week 1, 2, 4, 8, 12, 24 and 36
Title
Geriatric Depression Inventory-Self-Report
Description
The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms.
Time Frame
between baseline and week 4, 8, 12, 24 and 36
Title
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
Description
change of NT-ProBNP level
Time Frame
between baseline and week 12, and between baseline and week 36
Title
cardiac function
Description
change of ejection fraction as measured with ultrasound cardiogram
Time Frame
between baseline and week 12, and between baseline and week 36
Title
Minnesota living with heart failure questionnaire
Description
The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life.
Time Frame
between baseline and week 4, 8, 12, 24 and 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between 60 -85 years old.
male or female.
Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
Reading and writing competency for completing the rating scales.
Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.
Exclusion Criteria:
Currently taking antidepressant drugs, and drug dose is unstable.
With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
Intact cognitive function with CSI-D score of less than 7.
Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
Planned heart surgery within 9 months.
Unable to comply with psychological intervention due to serious physical conditions -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huali Wang, PhD
Phone
+86 010-82801983
Email
huali_wang@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Zhang
Email
zhangying0603@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huali Wang, PhD
Organizational Affiliation
Peking University Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua He, MD
First Name & Middle Initial & Last Name & Degree
Jianhua He, MD
First Name & Middle Initial & Last Name & Degree
Jin Yi, MD
First Name & Middle Initial & Last Name & Degree
Yulan Liang
First Name & Middle Initial & Last Name & Degree
Na Zhang, MD
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongdong Hu
First Name & Middle Initial & Last Name & Degree
Yongdong Hu
Facility Name
Beijing Chaoyang Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanxin Ma
Facility Name
Beijing Fengtai Tieying Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiyun Sun
First Name & Middle Initial & Last Name & Degree
Peiyun Sun
First Name & Middle Initial & Last Name & Degree
Ning Li
Facility Name
Beijing Tiancun Community Health Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingling Yang
First Name & Middle Initial & Last Name & Degree
Qingling Yang
First Name & Middle Initial & Last Name & Degree
Jing Sun
First Name & Middle Initial & Last Name & Degree
Chong Zhang
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Zhu
First Name & Middle Initial & Last Name & Degree
Yun Zhu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.
IPD Sharing Time Frame
After the results of primary outcome are published. The data will be available for 2 years.
IPD Sharing Access Criteria
Those who are interested in the study should submit a synopsis of research plan for administrative approval by the study committee. Once the data sharing plan is approved by the study committee, the researcher should submit a IRB approval from host institution. When the IRB approval is received, the study committee will ask the data manager to transfer the data for further analysis.
Citations:
PubMed Identifier
31132996
Citation
Zhang Y, Lv X, Jiang W, Zhu Y, Xu W, Hu Y, Ma W, Sun P, Yang Q, Liang Y, Ren F, Yu X, Wang H. Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial. BMC Psychiatry. 2019 May 27;19(1):161. doi: 10.1186/s12888-019-2135-2.
Results Reference
derived
Learn more about this trial
Psycho-behavioral Intervention for Depression in Chronic Heart Failure
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