Psycho-behavioral Intervention for Depression in Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Psycho-behavioral intervention


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>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. | Behavioral: Psycho-behavioral intervention<br>* The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.<br>|
| No Intervention: control group<br>Subjects will receive usual care and be contacted as same frequent as the intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |