Psycho-behavioral Intervention for Depression in Chronic Heart Failure

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233451
• Other study ID #: 2016-1-4117
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Peking University
• Contact: Huali Wang, PhD
• Phone: +86 010-82801983
• Email: huali_wang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Heart Failure

Intervention

Behavioral:
• Psycho-behavioral intervention
The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing
China	Beijing Chaoyang Third Hospital	Beijing
China	Beijing Fengtai Tieying Hospital	Beijing
China	Beijing Tiancun Community Health Center	Beijing
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	cardiac function	change of ejection fraction as measured with ultrasound cardiogram	between baseline and week 12, and between baseline and week 36
Secondary	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