Psycho-behavioral Intervention for Depression in Chronic Heart Failure

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: Psycho-behavioral intervention

• Registration Number: NCT03233451
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-28
• Study Start: 2017-08-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-09
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

1. between 60 -85 years old.
2. male or female.
3. Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
4. 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.
5. Reading and writing competency for completing the rating scales.
6. Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.

Exclusion Criteria

1. Currently taking antidepressant drugs, and drug dose is unstable.
2. 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).
3. Intact cognitive function with CSI-D score of less than 7.
4. Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
5. Planned heart surgery within 9 months.
6. Unable to comply with psychological intervention due to serious physical conditions -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Psycho-behavioral intervention	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.

Primary Outcome Measures

Name	Time	Method
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version	between baseline and week 12	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

Name	Time	Method
Geriatric Depression Inventory-Self-Report	between baseline and week 4, 8, 12, 24 and 36	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.
cardiac function	between baseline and week 12, and between baseline and week 36	change of ejection fraction as measured with ultrasound cardiogram
Minnesota living with heart failure questionnaire	between baseline and week 4, 8, 12, 24 and 36	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.
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version	between baseline and week 1, 2, 4, 8, 24 and 36	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	between baseline and week 4, 8, 12, 24 and 36	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	between baseline and week 1, 2, 4, 8, 12, 24 and 36	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.
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)	between baseline and week 12, and between baseline and week 36	change of NT-ProBNP level

Trial Locations

Locations (6)

Beijing Chaoyang Third Hospital; 🇨🇳 Beijing, China

Beijing Fengtai Tieying Hospital; 🇨🇳 Beijing, China

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Tiancun Community Health Center; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China