Psycho-behavioral Intervention for Depression in Chronic Heart Failure

Peking University

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Psycho-behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03233451

2016-1-4117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups

Interventional group

Experimental group

Description:

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.

Treatment:

Behavioral: Psycho-behavioral intervention

control group

No Intervention group

Description:

Subjects will receive usual care and be contacted as same frequent as the intervention group.