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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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. |
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| control group | No Intervention | Subjects will receive usual care and be contacted as same frequent as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psycho-behavioral intervention | Behavioral | The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between baseline and week 1, 2, 4, 8, 24 and 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huali Wang, PhD | Contact | +86 010-82801983 | huali_wang@bjmu.edu.cn | |
| Ying Zhang | Contact | zhangying0603@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huali Wang, PhD | Peking University Institute of Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31132996 | Derived | 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. |
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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.
After the results of primary outcome are published. The data will be available for 2 years.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2018 | Mar 24, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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). |
| between baseline and week 4, 8, 12, 24 and 36 |
| 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. | between baseline and week 1, 2, 4, 8, 12, 24 and 36 |
| 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. | between baseline and week 4, 8, 12, 24 and 36 |
| amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP) | change of NT-ProBNP level | between baseline and week 12, and between baseline and week 36 |
| cardiac function | change of ejection fraction as measured with ultrasound cardiogram | between baseline and week 12, and between baseline and week 36 |
| 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. | between baseline and week 4, 8, 12, 24 and 36 |
| Beijing Chaoyang Hospital, Capital Medical University | Recruiting | Beijing | China |
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| Beijing Chaoyang Third Hospital | Recruiting | Beijing | China |
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| Beijing Fengtai Tieying Hospital | Recruiting | Beijing | China |
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| Beijing Tiancun Community Health Center | Recruiting | Beijing | China |
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| Peking University Third Hospital | Recruiting | Beijing | China |
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