An interventional study of Psycho-behavioral intervention in Depression, sponsored by Peking University. Status unknown at 6 sites in China. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Peking University · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 236 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Subjects will receive usual care and be contacted as same frequent as the intervention group.
The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
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.
Time frame: between baseline and week 12
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: between baseline and week 12, and between baseline and week 36
cardiac function
change of ejection fraction as measured with ultrasound cardiogram
Time frame: 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.
Time frame: between baseline and week 4, 8, 12, 24 and 36
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Csr, Analytic code
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Peking University